MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.045S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2020.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent surgery where cephalic screw and tfna nail were implanted.Five (5) months later, the patient presented to the doctor's office with pain.An x-ray showed the split nail.On (b)(6) 2020 revision surgery was performed to extract the tfna nail due to implant failure as the nail split in the cephalic part.The surgeon repositioned a new tfna nail and lag screw.It was reported that the nail broke within the patient three (3) months after placement.No further information was provided.This report is for one (1) 10mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for (b)(4).

Event Description

Updated event description concomitant devices reported: unknown locking screws (part# unknown, lot# unknown, quantity# unknown), tfna scr perf l95 tan (part# 04.038.195, lot# 3l42408, quantity# 1).This complaint involves one (1) device.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 17-june-2019, expiration date: 01-jun-2029, part number: 04.037.045s, 10mm/130 deg ti cann tfna 235mm/left ¿ sterile, lot number: 10l0839 (sterile) , lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final, ns071281 rev e met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lmd rev ad was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16374 supplied by ees (albuquerque) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.942.2, lock prong, 130 degree, lot number: 3l41810, lot quantity: 56.Production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, ns073593 rev b met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended lot number: h761693, lot quantity: 1,000.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by smalley dated 27-nov-2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive lot number: 3l23467 lot quantity: 149.One piece was scrapped in cell at op #50, inspect 1, for a damaged thread.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet ns062925 rev e met all inspection acceptance criteria apart from the one piece noted.Part number: 21127, timoagri16.00 bp80 lot number: h870510 lot quantity: 3,430 lbs.Certificate of test supplied by ati specialty materials dated 06-mar-2019 was reviewed and determined to be conforming.Lot summary report dated 03-apr-2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review oct 20, 2020: dhr reviewed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d9: updated h3, h6: investigation summary investigation flow: damage visual inspection: the tfna fem nail ø10 le 130° l235 timo15 (part #: 04.037.045s, lot #: 10l0839) was received at us cq.Upon visual inspection, the nail has broken into two distinct fragments which were returned.No nail marks were visible in the area of the breakage except nicks.Device failure/defect was identified.Document/specification review: no design issues or discrepancies were identified.The complaint was confirmed.Investigation conclusion: this complaint is confirmed as the device was received being broken into two pieces.No definitive root cause could be determined based on the provided information.It is likely that the device experienced external forces higher than what the device was validated to withhold.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot manufacturing location: monument.Manufacturing date: jun 17, 2019.Expiration date: jun 01, 2029.Part number: 04.037.045s, 10mm/130 deg ti cann tfna 235mm/left ¿ sterile.Lot number: 10l0839 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final, ns071281 met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, ns067861 met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16374 supplied by ees (albuquerque) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.942.2, lock prong, 130 degree.Lot number: 3l41810.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, ns073593 rev b met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: h761693.Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by smalley dated nov 27, 2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive.Lot number: 3l23467.Lot quantity: (b)(4).One piece was scrapped in cell at op #50, inspect 1, for a damaged thread.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet ns062925 met all inspection acceptance criteria apart from the one piece noted.Part number: 21127, timoagri16.00 bp80 lot number: h870510.Lot quantity: (b)(4).Lbs.Certificate of test supplied by ati specialty materials dated mar 06, 2019 was reviewed and determined to be conforming.Lot summary report dated apr 03, 2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review: oct 20, 2020: dhr reviewed device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10803200
• MDR Text Key: 217428836
• Report Number: 8030965-2020-08716
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096012
• UDI-Public: (01)10886982096012
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.045S
• Device Catalogue Number: 04.037.045S
• Device Lot Number: 10L0839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/12/2021
• Patient Sequence Number: 1
• Treatment: TFNA SCR PERF L95 TAN; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention