| Model Number 200-24-030, 200-24-036, 200-24-038 |
| Device Problems
Difficult to Remove (1528); Structural Problem (2506); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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| Event Date 05/24/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation summary: an event was reported where three tiger cannulated stripped during a removal case which caused a delay in surgery.The case was completed successfully and all screws were removed although the surgeon had to use "extreme force and two sets of pliers".The three screws were returned to corporate for evaluation.Dhr review: a dhr review was not able to be completed as lot numbers are not known.Visual and dimensional inspection: the three malfunctioning screws were returned to corporate and visually reviewed.All were confirmed to be stripped and/or broken as reported.Parts were not able to be dimensionally inspected as the drive feature was completely stripped, as reported in the event.There were no deficiencies alleged regarding the other features of the screw (overall length, threads, etc.) and no dimensions were evaluated.Review of similar complaints: review of similar complaints in the past 12 months found (b)(4) complaints in which the driver and screw exhibited poor engagement or retention: (b)(4).The majority of these complaints were unable to determine a root cause.(b)(4) complaints were identified in the past 12 months for tiger cannulated screws causing pain leading to a removal (not related to another system).Reference: (b)(4).Simulated use testing: simulated use testing was not able to be completed due to the state of the returned screws.The driver used during the case was not returned for evaluation or simulated use testing.Review of the case details: the event specified that the surgeon attempted to engage the screws with the given 210-24-003 2.0/2.4 tiger cannulated driver bit.The driver stripped the screws and the surgeon opted to use needle-nose pliers and used "extreme force" to remove the screws with no other complications.A review of the ifu for the tiger cannulated system, ifu (b)(4) identified two suggestions during screw removal if the screw stripped.Steps 4 and 5 of the screw removal process are available for review below: optional: if the screw head is stripped, engage the proximal shaft under the screw head with the screw removal tool and continue turning counterclockwise while exerting light pressure upwards with the removal tool.If the screw is integrated into bone, core out with trephine drill.The surgeon did not follow the ifu during the removal after the screw stripped, which is the most likely root cause of the excessive surgical delay in this event.Conclusion and root cause analysis a dhr review was not able to be completed due to unknown lot numbers.Visual inspection of the returned parts confirmed the reported event; the screws were stripped.A review of previous complaints identified (b)(4) additional complaints where tiger cannulated screws and drivers had poor engagement, as reported in the event details.Simulated use testing was not able to be completed.The review of the case details identified that the surgeon deviated from the ifu during the removal and utilized pliers instead of the screw removal tool and/or a trephine drill, which is likely what caused the delay in surgery.The root cause of the stripped screws was not able to be identified during the investigation, but was likely caused by poor driver-screw engagement as detailed in the event or due to the screw becoming integrated into the bone causing excessive force to be required to remove the screw.Capa (b)(4) is currently investigating screw/driver engagement in the tiger cannulated system.Investigation summary: an event was reported where three tiger cannulated stripped during a removal case which caused a delay in surgery.The case was completed successfully and all screws were removed although the surgeon had to use "extreme force and two sets of pliers".The three screws were returned to corporate for evaluation.Dhr review: a dhr review was not able to be completed as lot numbers are not known.Visual and dimensional inspection: the three malfunctioning screws were returned to corporate and visually reviewed.All were confirmed to be stripped and/or broken as reported.Returned 200-24-030 screw with observed break, stripped drive feature and damaged head.Returned 200-24-036 screw with observed drive feature stripped and damaged head.Returned 200-24-038 screw with observed drive feature stripped.Parts were not able to be dimensionally inspected as the drive feature was completely stripped, as reported in the event.There were no deficiencies alleged regarding the other features of the screw (overall length, threads, etc.) and no dimensions were evaluated.Review of similar complaints: review of similar complaints in the past 12 months found (b)(4) complaints in which the driver and screw exhibited poor engagement or retention: (b)(4).The majority of these complaints were unable to determine a root cause.Simulated use testing: simulated use testing was not able to be completed due to the state of the returned screws.The driver used during the case was not returned for evaluation or simulated use testing.
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Event Description
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On (b)(6) 2019, (b)(6) reported that dr.(b)(6) had a lda tiger screw removal on (b)(6) 2019 at (b)(6) hospital with a female patient that was reporting pain in her 2nd, 3rd, and 4th proximal phalanxes.The screws were originally implanted on (b)(6) 2019, (b)(6) hospital by dr.(b)(6).Dr.(b)(6) had difficulty backing the screws out with the given 210-24-003 (2.0/2.4 tiger cannulated driver bit) driver in (b)(6) personal tiger cannulated set.After the driver had completely stripped the screws, the driver would no longer engage with the tiger screw heads.Dr.(b)(6) opted to use needle-nose pliers that he had on hand in the operating room.(b)(6) reported that the screws "were so stripped that the pliers dr.(b)(6) completely broke after trying to pull the screws out with much force." to complete the removal, dr.(b)(6) had to use "extreme force and two sets of pliers" whilst breaking the screw head off of one lda screw to remove all the hardware associated with the patient's reported pain.The surgical time was extremely delayed due to this malfunction, but all the screws were all removed and the surgical site was healed to dr.(b)(6) satisfaction so there was no further intervention or additional hardware required.The tiger screws (200-24-030 (2.4 x 30mm tiger cannulated screw), 200-24-036 (2.4 x 36mm tiger cannulated screw), 200-24-038, (2.4 x 38mm tiger cannulated screw)) have all been returned to corporate for further review.
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Manufacturer Narrative
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Notes to form 3500a and justification for information not provided (in initial or follow-up submission) as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-9 below) as part of internal complaint handling activities.1.Patient age at time of event, date of birth (a2) and weight (a4) not reported.2.Date of event (b3) is unknown.The event is considered to be the onset of patient pain.3.Catalog # and serial # (d4) not utilized by trilliant surgical.4.Expiration date (d4) not applicable (n/a) to non-sterile trilliant surgical products.5.Reprocessor name and address (d9) n/a to this report.6.Concomitant medical products and therapy dates (d11) not reported.7.Device manufacture date (h4) listed below in the additional investigation section.8.Section h9 n/a to this report.9.No files attached to this report.Corrected information provided in follow-up submission: b2 - other serious is selected (in addition to required intervention) to account for surgical time delay.B5 - description of event or problem was edited to not identify any physician or institution by name.D2 - common device name corrected, product code was correct in initial submission.D3 - fax number added.D4 - model #, catalog #, serial #.D10 - returned to manufacturer date corrected.E1 - initial reporter corrected to physician who reported the event to the sales representative.Sales representative's email is deleted.Address corrected.Section f n/a to this report.G1, g2 - fax number added.G3 - health professional and distributor selected, while company representative is deleted.H6 - to account for patient pain: patient code 1994, device code 2993, methode code 3331, result code 3221, conclusion code 4315; to account for difficult removal: patient code 2692, device codes 1528-2919-2976-568, methode codes 4111-10-4109-3331, result codes 3243-4206, conclusion code 18.H10 - corrected data - investigation summary in initial submission was duplicated.Below is the correct investigation summary.Additional information provided in follow-up submission: d4 - lot #, unique identifier (udi) #.G1 - name, email, telephone updated as different personnel is submitting the follow-up submission than submitted the initial submission.H10 - additional manufacturer narrative.Investigation summary: an event was reported where three (3) tiger cannulated screws stripped during a removal case which caused a delay in surgery.The case was completed successfully and all screws were removed although the surgeon had to use "extreme force and two sets of pliers".The three (3) screws were returned to corporate for evaluation.Visual and dimensional inspection: the three (3) malfunctioning screws were returned to corporate and visually reviewed.All were confirmed to be stripped and/or broken as reported.Parts were not able to be dimensionally inspected as the drive feature was completely stripped, as reported in the event.There were no deficiencies alleged regarding the other features of the screw (overall length, threads, etc.) and no dimensions were evaluated.Review of similar complaints: review of similar complaints in the past 12 months found 18 complaints in which the driver and screw exhibited poor engagement or retention.The majority of these complaints were unable to determine a root cause.No complaints were identified in the past 12 months for tiger cannulated screws breaking during insertion or removal.Simulated use testing: simulated use testing was not able to be completed due to the state of the returned screws.The driver used during the case was not returned for evaluation or simulated use testing.Review of the case details: a review of the ifu for the tiger cannulated system, ifu 900-01-002 rev p, identified two (2) suggestions during screw removal if the screw stripped.Steps 4 and 5 of the screw removal process are available for review below: 4.Optional: if the screw head is stripped, engage the proximal shaft under the screw head with the screw removal tool and continue turning counterclockwise while exerting light pressure upwards with the removal tool.5.If the screw is integrated into bone, core out with trephine drill.The surgeon did not follow the ifu during the removal after the screw stripped, which is the most likely root cause of the excessive surgical delay in this event and also caused the screw to break.Conclusion and root cause analysis: visual inspection of the returned parts confirmed the reported event: the screws were stripped.A review of previous complaints identified 18 additional complaints where tiger cannulated screws and drivers had poor engagement, as reported in the event details.Simulated use testing was not able to be completed.The review of the case details identified that the surgeon deviated from the ifu during the removal and utilized pliers instead of the screw removal tool and/or a trephine drill, which is likely what caused the delay in surgery.The root cause of the stripped screws was not able to be identified during the investigation, but was likely caused by poor driver-screw engagement as detailed in the event or due to the screw becoming integrated into the bone causing excessive force to be required to remove the screw.Additional investigation conducted 03/23/2020: lot numbers were identified for this event.The corresponding dhrs were reviewed for any significant events (i.E.Nonconformances, reworks, deviations) that may correlate to the reported event.No adverse events were identified.As a result of the dhr review, it is concluded that there are no identified issues correlating to the reported event.Lot 75dk1216, manufactured 09/23/2011.Lot 75ki1222, manufactured 03/25/2010.Lot tsl001474, manufactured 08/11/2014.
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Event Description
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On 05/24/2019, a trilliant surgical sales representative reported that doctor 1 had an lda tiger screw removal on (b)(6) 2019 at hospital x with a female patient that was reporting pain in her 2nd, 3rd, and 4th proximal phalanxes.The screws were originally implanted on (b)(6) 2019 at hospital x by doctor 1.Doctor 1 had difficulty backing the screws out with the given 2.0/2.4mm cannulated screw driver bit (210-24-003) in the sales representative's personal tiger cannulated set.After the driver had completely stripped the screws, the driver would no longer engage with the tiger screw heads.Doctor 1 opted to use needle-nose pliers that he had on hand in the operating room.The sales representative reported that the screws "were so stripped that the pliers doctor 1 used completely broke after trying to pull the screws out with much force".To complete the removal, doctor 1 had to use "extreme force and two sets of pliers" whilst breaking the screw head off of one lda screw to remove all the hardware associated with the patient's reported pain.The surgical time was extremely delayed due to this malfunction, but all the screws were all removed and the surgical site was healed to doctor 1's satisfaction so there was no further intervention or additional hardware required.The tiger screws (2.4mm x 30mm tiger cannulated screw, 200-24-030; 2.4mm x 36mm tiger cannulated screw, 200-24-036; and 2.4mm x 38mm tiger cannulated screw, 200-24-038) have all been returned to corporate for further review.
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Search Alerts/Recalls
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