MAUDE Adverse Event Report: TRILLIANT SURGICAL 10MM STERILE STAPLE KIT ASSEMBLY; STERILE SNIPER STAPLE SYSTEM

Model Number 500-10-001

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Wound Dehiscence (1154); Fall (1848); Unspecified Infection (1930); Organ Dehiscence (2502)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: an event was reported where a 10 mm sniper staple, utilized from a 500-10-001 sniper staple sterile kit, had begun to back out of the surgical site.The staple was initially implanted on (b)(6) 2019 and was removed in-office on (b)(6) 2019 due to an unkept surgical site with suspected infection and due to patient noncompliance, such as walking too soon and failing to utilize the walking boot.The surgeon was satisfied with the fusion that had occurred and re-fixation was not necessary.The infection was not confirmed, however, the site was cleaned and closed to prevent further infection.The surgeon specifically stated that "the infection had no correlation to the 10 mm staple and it was due to patient noncompliance".The lot numbers are unknown and parts were not returned to corporate for evaluation.Therefore, a dhr review, dimensional/visual verification, and simulated use testing were not able to be completed.Review of case details: the event details were reviewed and it was identified that the initial implantation of the 10 mm staple on (b)(6) 2019 was successful and there was no complaint associated with that implantation.The reporter specifically stated that patient noncompliance was confirmed and caused the backing out of the implant and the suspected infection.Previous complaints review: the complaints log was reviewed for parts 500-08-001/101, 500-10-001/101, 500-12-001/101 to ensure similar staples in both the sterile and non-sterile configurations were considered.The complaints log was reviewed in it's entirety and did not identify any other complaints where the staple backed out of the surgical site causing a removal.Summary: as stated in the event description, the most likely root cause of the staple backing out of the surgical site requiring a removal is due to patient noncompliance.The previous complaints review did not identify any concerning trends and the field shall be continued to be monitored.

Event Description

On 09/05/2019, our sales representative reported that on (b)(6) 2019, the surgeon had a (b)(6) male patient come into his office with an unkept surgical site reporting of a potential infection.The patient reported that he was noncompliant by walking too soon and failing to use the suggested walking boot when engaging in any activity.The surgeon reviewed the surgical site and noticed that the closure had partially dehisced and that the implanted 10 mm sniper staple (used originally from a 500-10-001 10 mm sniper staple sterile kit) had begun to back out of the surgical site.The 10 mm staple was originally implanted on (b)(6) 2019 at (b)(6) hospital during an ipj fusion which rendered successful results.The surgeon stated that "the infection had no correlation to the 10 mm staple and it was due to patient noncompliance." it is unknown the lot number of the staple in question as two separate sterile staple kits were used in the original surgery.The surgeon decided to remove the 10 mm staple in office on (b)(6) 2019 as he was satisfied with the results of the observed fusion.Robert vitale stated that the surgeon cleaned the wound site and closed the surgical site after the staple removal with a few steri-strips and additional adhesive barrier to prevent further infection.The 10 mm staple was kept by the surgeon and our sales representative followed up that it cannot be returned to corporate for further review.It is unknown the lot number of the staple in question as two separate sterile staple kits were used in the original surgery.

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 1-8 below) as part of internal complaint handling activities.1.Patient date of birth (a2) and weight (a4) not reported.2.Catalog # and serial # (d4) not utilized by trilliant surgical.3.Lot #, expiration date, and unique identifier (udi) # (d4) could not be confirmed.See below for possibilities.4.Reprocessor name and address (d9) n/a to this report.5.Concomitant medical products and therapy dates (d11) not reported.6.As a result of item 3 above, device manufacture date (h4) could not be confirmed.See below for possibilities.7.Section h9 n/a to this report.8.No files attached to this report.Corrected information provided in follow-up submission: b1 - adverse event and product problem are selected.B5 - description of event/problem for initial submission - corrected to not identify any physician or institution (or sales personnel) by name.D2 - common device name corrected (product code was correct in initial submission).D3 - fax number added.D4 - model #, catalog #, serial #.D5 - operator of device at the time of the event is corrected to patient as the patient admitted to noncompliance.E1 - initial reporter corrected to the doctor who reported the event to the sales representative.Sales representative's email address removed.Section f is n/a to this report.G1, g2 - fax number added g3 - health professional and distributor are selected, company representative is deleted.H10 - corrected data.Additional information provided in follow-up submission: d4 - lot #.G1 - name, telephone, and email address updated as different personnel is submitting the follow-up submission than submitted the initial submission.H10 - additional manufacturer narrative.Additional investigation conducted 03/20/2020: the following lot numbers were identified as possibilities for this event upon review of associated sales data.The corresponding device history records (dhrs) were reviewed for any significant events (i.E.Nonconformances (ncrs), reworks (rwks), deviations) that may correlate to the reported event.Lot tsl006162 [udi (b)(4) manufactured 08/01/2018, expiration date 05/01/2023] - no ncrs, rwks, or deviations.Lot tsl006687 [udi (b)(4), manufactured 12/13/2018, expiration date 09/01/2023] - no deviations or rwks; ncr 18-487.Ncr 18-487 was initiated for a single staple kit not having a trilliant surgical logo sticker and does not affect the performance of the staple.The dhr review was unable to provide additional insight to the root cause of the event reported in section b5 where the staple backed out and the surgical site became infected following patient noncompliance.As a result of the dhr review findings, there is no correlation to the reported event.

Event Description

On 09/05/2019, a trilliant surgical sales representative reported that doctor 1 had a 65-year-old male patient come into his office with an unkept surgical site reporting of a potential infection on (b)(6) 2019.The patient reported that he was noncompliant by walking too soon and failing to use the suggested walking boot when engaging in any activity.Doctor 1 reviewed the surgical site and noticed that the closure had partially dehisced and that the implanted 10mm sniper staple (used originally from a 10mm sterile staple kit assembly, 500-10-001) had begun to back out of the surgical site.The 10mm staple was originally implanted on (b)(6) 2019 at hospital 1 during an ipj fusion which rendered successful results.Doctor 1 stated, "the infection had no correlation to the 10mm staple and it was due to patient noncompliance." as of 09/05/2019, the lot number of the staple in question is unknown as two (2) separate sterile staple kits were used in the original surgery.Doctor 1 decided to remove the 10mm sniper staple in-office on (b)(6) 2019 as he was satisfied with the results of the observed fusion.The sales representative stated that doctor 1 cleaned the wound site and closed the surgical site after the staple removal with a few steri-strips and additional adhesive barrier to prevent further infection.The 10mm sniper staple was kept by doctor 1 and the sales representative is following up to determine if it can be sent back to corporate for further review.

• Brand Name: 10MM STERILE STAPLE KIT ASSEMBLY
• Type of Device: STERILE SNIPER STAPLE SYSTEM
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• MDR Report Key: 9136975
• MDR Text Key: 166190325
• Report Number: 3007420745-2019-00042
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K162354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 500-10-001
• Device Catalogue Number: 500-10-001
• Device Lot Number: SEE SECTION H10.
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/05/2019
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR