MAUDE Adverse Event Report: SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 380MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.129S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020, that the patient underwent for a revision procedure.A tfna nail had broken at the lag screw site.A replacement tfna nail is inserted.It was unknown if the procedure completed successfully.The patient condition was unknown.Concomitant devices reported: unknown locking screw (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for (1) 11mm/125 deg ti cann tfna 380mm/left - sterile.This report is 1 of 1 for (b)(4).

Event Description

It was reported, that patient underwent revision surgery on (b)(6) 2020 due to a broken trochanteric fixation nail advanced (tfna).The patient presented in hospital with pain on (b)(6) 2020 x-ray analysis shoed the nail broken at the lag screw site.The patient did not have any trauma reported and it is unknown when the break occurred.

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.H3, h6: manufacturing location: monument manufacturing date: april 30, 2019, expiration date: april 01, 2029, part: 04.037.129s, 11mm/125 deg ti cann tfna 380mm/left- sterile, lot: h825031 (sterile).One piece was scrapped after a tooling breakage.One piece was scrapped as a destructive test.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Sterilization control number (scn) supplied by ethicon (abq) 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: 04.037.912.2, lock prong, 125 degree tfna, bp55, lot: 3l72395, purchased finished goods traveler met all inspection acceptance criteria.Part: 04.037.912.4, wave spring, shim ended, bp55, lot: h761692, work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley were reviewed and determined to be conforming.Part: 04.037.912.3, tfna lock drive, bp58, lot: h831521.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part: 21127, timoagri16.00, bp80, lot: h804600.Certificate of analysis supplied by metalwerks inc.Was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Visual inspection: the received nail is broken apart at the nail's head.The breakage point is located in the middle of the oblique hole.Furthermore, there are several mechanical damages visible on the surface.In general, the device is in a very used condition with discolorations and scratches all over.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: feature: outer diameter head result: pass feature: inner diameter (near breakage point) result: pass.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Furthermore, as indicated in the manufacturing documents, the correct material was used according to iso 5832-11 summary: the complaint condition is confirmed as the nail was found broken.The complaint relevant dimensions were checked as far as possible and found to be within specifications.This lot was manufactured in april 2019; all devices are distributed and we are not aware of any other complaint for this part- and lot number combination.This, and the findings above, let us exclude a manufacturing related issue.Based on the provided information, we are not able to determine the exact cause of this breakage.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal-union, overloading of the osteosynthesis, or a combination of different factors, did lead to a fatigue failure.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.D6: date of implant reported as late in (b)(6) 2020.

Event Description

Update: 12/28/2020: updated event description: the original nail was implanted late (b)(6)2020.Concomitant devices reported: tfna screw (part#: 04.038.205, lot# 10l8076, qty.1); locking screws (part# 04.005.532, lot# 3l54231, qty.2); tfna end cap (part# 04.038.000, lot# 64p7222, qty.1).This complaint involves one (1) device.

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.D6a, d6b: date of implant (b)(6) 2020 & date of explant (b)(6) 2020 provided for reporting.D11: concomitant products added to complaint.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: 11MM/125 DEG TI CANN TFNA 380MM/LEFT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11068130
• MDR Text Key: 224245419
• Report Number: 8030965-2020-09949
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650398
• UDI-Public: (01)07611819650398
• 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: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.129S
• Device Lot Number: H825031
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 01/21/2021
• Patient Sequence Number: 1
• Treatment: END-CAP EXTENS. 0 TAN3.; LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN.; LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN.; TFNA FEM NAIL Ø11 LE 125° L380 TIMO15.; TFNA SCR PERF L105 TAN.; UNK - NAIL HEAD ELEM: TFNA LAG SCREW.; UNK - SCREWS: LOCKING.
• Patient Outcome(s): Required Intervention