MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/125 DEG TI CANN TFNA 340MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.225S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that in (b)(6) 2017, the patient underwent the surgery by using a competitors femoral implant system in order to prevent bone fractures due to the breast cancer being spread to the femur.On (b)(6) 2020, a revision surgery was performed to replace the femoral implants due to device breakage with synthes trochanteric fixation nail antirotation (tfna) long implants.On (b)(6) 2020, a revision surgery was performed due to the breakage of the tfna long implants.The patient was revised to another set of implants.There was a one (1) hour surgical delay due to extended time in removing the broken device.It was further reported the patient also had a non-union which may have contributed to the device breakage.This is report 1 of 5 for (b)(4).
Additional 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.Investigation summary: investigation site: customer quality (cq) zuchwil, selected flow: damaged.Visual inspection: the received tfna nail is broken apart at the nail-head, between the transversal hole.Furthermore, the locking prong was found deformed.There are several mechanical damages visible on the surface.In general is the device is in a very used condition with discolorations and scratches all over.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: feature: caliper: 3-01-19788 dimension drawing: dimension measured: result: pass.Feature: inner diameter at fracture face caliper: 3-01-19788 dimension drawing: dimension measured: result: pass.Feature: bore centricity caliper: 3-01-19788 dimension drawing: dimension measured: 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 and that the material was according to norm astm f2066, standard specification for wrought titanium-15 molybdenum alloy for surgical implant applications.Summary: the complaint condition is confirmed as the nail was found broken.The for the complaint relevant dimensions were checked as far as possible and found to be within specifications, no manufacturing related issue could be detected.We are not able to determine the exact cause of this breakage.Based on the provided information we can only assume that any occurrence during the healing process, like the mentioned non-union, did lead to a fatigue failure of the nail.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 history lot: manufacturing location: monument, manufacturing date: april 8, 2019, expiration date: april 1, 2029, part number: 04.037.225s, 12mm/125 deg ti cann tfna 340mm/left- sterile, lot number: h869301 (sterile).Two pieces were scrapped in cell at op #30, gundrill, due to a cannulation run-out failure.The remainder of the lot was 100% inspected for this feature and determined to be acceptable.Work order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, in-process / inspect dimensional / final ns071306 rev e met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, tfna assembly inspection ns067861 rev b met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev ac was reviewed and determined to be conforming.Scn 16193 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 number: 04.037.912.2, lock prong, 125 degree, tfna, bp55 lot number: 3l87189 purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55 lot number: h761704 work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated november 20, 2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive, bp58 lot number: h853428 work order traveler met all inspection acceptance criteria.Inspection sheet, ns062925 rev e met all inspection acceptance criteria.21127, timoagri16.00, bp80 lot number: h846839 certificate of analysis supplied by metalwerks inc.Dated january 31, 2019 was reviewed and determined to be conforming.Lot summary report dated february 28, 2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review: july 14, 2020: dhr reviewed by: mschoenfeld 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.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: 12MM/125 DEG TI CANN TFNA 340MM/LEFT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10343455
• Report Number: 8030965-2020-05430
• Device Sequence Number: 803775
• Product Code: HSB
• UDI-Device Identifier: 10886982097118
• UDI-Public: (01)10886982097118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.225S
• Device Catalogue Number: 04.037.225S
• Device Lot Number: H869301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA HELICAL BLADE L80 TAN; LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA HELICAL BLADE L80 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 52