MAUDE Adverse Event Report: TRILLIANT SURGICAL 3.0MM X 18MM TIGER CANNULATED SCREW; TIGER CANNULATED SCREW SYSTEM SCREW

Model Number 200-30-018

Device Problems Difficult to Remove (1528); Structural Problem (2506); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

An event was reported where a tiger cannulated screws stripped during a removal case leading to a delay in surgery of "about 45 minutes".A review of the surgical technique, visual inspection of returned parts, and a review of previous complaints was completed to determine the root cause of the event.The driver was not returned and there are no known lot numbers for the hardware so a dhr review cannot be completed.Review of surgical technique: review of the case details shows that the physician utilized a 210-40-003 3.0/4.0 tiger cannulated driver to attempt to remove the 3.0 mm tiger cannulated screw, which is the correct pairing of driver to screw.It was provided that the screw had been implanted long enough that the surgical site had healed and was not causing pain, however, the length of implantation is unknown.The screw stripped within the first few "turns" of the 210-40-003 driver.Although not indicated by the ifu (900-01-002 rev p), a k-wire was inserted to attempt to feed the screw out of the surgical site, but this did not help get the screw removed.Eventually dr.(b)(6) utilized a small osteotome to provide space and then used a "needle holder" to pull the screw the rest of the way out.The screw was eventually successfully removed and no additional complications were reported.The ifu specifies that the use of a screw removal tool should be used after the screw has stripped, however, the use of the osteotome and needle holders did not contribute to the event of the screw stripping.A root cause for the screw stripping was not identified during the review of the surgical technique.Visual inspection: the returned screw was visually inspected and was severely stripped.There was no discoloration or damage observed on any other potions of the screw.The screw was not dimensionally inspected due to the extent of the damage.Simulated use testing was also not possible as the driver was not returned and the screw is severely damaged.Previous complaints review (past 12 months): the complaints log was reviewed for any complaints related to tiger cannulated screws stripping during a removal.A total of 11 complaints were identified, 12 including this complaint.All complaints were reviewed and identified that the majority of the root causes were identified as unknown or poor screw/driver engagement.Conclusion: visual inspection of the returned screw confirmed the event.The screw head was completely stripped.Review of previous complaints identified 11 additional events in the apst 12 months related to this event which did not have definitive root causes.The review of the surgical technique did not provide any insight into what may have caused the screw stripping; the screw stripped after the first few turns with the appropriate mating driver.The root cause of this event is unknown and is potentially due to poor screw/driver engagement.

Event Description

On (b)(6) 2019, (b)(6) called in to corporate after a 210-40-003 (3.0/4.0 tiger cannulated driver bit) stripped a 3.0 tiger cannulated screw during a screw removal surgery with dr.(b)(6) at (b)(6) hospital.Additionally, the removal was not scheduled due to any reported pain / irritation; the removal was scheduled due to the patient wanting the hardware out after the surgical site was fully healed.(b)(6) noted that it took "45 additional minutes" to remove the screw as the 210-40-003 (3.0/4.0 tiger cannulated driver bit) stripped the 3.0 tiger screw (the length of the screw at this point is unknown).(b)(6), who was present at the latter half of the case, reported that dr.(b)(6) stripped the tiger screw head upon the first few "turns" with the 210-40-003.To complete the removal, dr.(b)(6) first attempted to utilize a k-wire (210-40-004) to help feed the screw out of the surgical site.After much time had lapsed and the screw / driver interface was bleak, dr.(b)(6) utilized a small osteotome to "provide some space between the head of the screw and the bone." dr.(b)(6) then utilized a "needle holder" to pull the screw the rest of the way out of the cortex.The removal was done successfully with that method and there were no additional complications reported.The 210-40-003 and 3.0 tiger cannulated screw will be returned to corporate for review.

Event Description

On 04/25/2019, a trilliant surgical sales representative called in to corporate after a 3.0/4.0mm cannulated screw driver bit (210-40-003) stripped a 3.0mm tiger cannulated screw during a screw removal surgery with doctor 1 at hospital x.Additionally, the removal was not scheduled due to any reported pain / irritation; the removal was scheduled due to the patient wanting the hardware out after the surgical site was fully healed.The sales representative noted that it took "45 additional minutes" to remove the screw as the 3.0/4.0mm cannulated screw driver bit (210-40-003) stripped the 3.0mm tiger cannulated screw (at this point, the length of the screw is unknown).The sales representative (who was present at the latter half of the case) reported that doctor 1 stripped the 3.0mm tiger cannulated screw head upon the first few "turns" with the 210-40-003.To complete the removal, doctor 1 first attempted to utilize a 0.045" x 6" k-wire standard (210-40-004) to help feed the screw out of the surgical site.After much time had lapsed and the screw / driver interface was bleak, doctor 1 utilized a small osteotome to "provide some space between the head of the screw and the bone".Doctor 1 then utilized a "needle holder" to pull the screw the rest of the way out of the cortex.The removal was done successfully with that method and there were no additional complications reported.The 3.0mm tiger cannulated screw was returned to corporate for review while the 210-40-003 was not.

Manufacturer Narrative

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 1-11 below) as part of internal complaint handling activities.Patient age at time of event, date of birth (a2) and weight (a4) not reported.Catalog # and serial # (d4) not utilized by trilliant surgical.Expiration date (d4) not applicable (n/a) to non-sterile trilliant surgical products.Lot # and unique identifier (udi) # (d4) could not be confirmed.See discussion below.Implanted date (d6) is not reported.Reprocessor name and address (d9) n/a to this report.Concomitant medical products and therapy dates (d11) not reported.As a result of item 4 above, device manufacture date (h4) could not be confirmed.Section h9 n/a to this report.No remedial action (h7) initiated.No files attached to this follow-up report.Corrected information provided in follow-up submission: b2 - outcomes attributed to adverse event is selected as other serious to describe that the surgery took an additional 45 minutes.Hospitalization shall not be selected.B5 - description of event or problem is corrected to not identify any physician or institution by name.D2 - common device name (product code was correct in initial submission).G3 - health professional and distributor are selected as report source while company representative is removed.Additional investigation performed 03/20/2020: lot numbers could not be identified for this event.From the field inventory receipt record (firr), it was determined that the 3.0mm tiger cannulated screw was identified as having a length of 18mm (pn: 200-30-018).The invoice number is unknown.The lot numbers were pulled for cases at hospital x prior to the explantation date that involved a 3.0mm x 18mm tiger cannulated screw.There were numerous lot numbers identified that are unable to be narrowed down to the specific case.Thus, device history record (dhr) review could not be conducted for this event.

• Brand Name: 3.0MM X 18MM TIGER CANNULATED SCREW
• Type of Device: TIGER CANNULATED SCREW SYSTEM SCREW
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• MDR Report Key: 8633230
• MDR Text Key: 146340686
• Report Number: 3007420745-2019-00030
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K153338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 200-30-018
• Device Catalogue Number: 200-30-XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other