MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.063S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is a synthes sales representative.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
It was reported that on august 26, 2021, the patient underwent a procedure due to a broken trochanteric femoral nailing advanced (tfna) nail.The nail broke at the helical blade/nail interface six months after implantation.The initial fracture was an intertrochanteric with subtrochanteric extension.The broken hardware was removed, and the non-union site was revised with ria bone graft and an angled blade plate.It is unknown if there was a surgical delay.Procedure outcome is unknown.This report is for a tfna nail.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4: expiration date h3, h4, h6: manufacturing location: monument.Manufacturing date: september 10, 2020.Expiration date: july 31, 2030.Part number: 04.037.063s, 10mm/130 deg ti cann tfna 420mm / left ¿ sterile.Lot number: 69p1867 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final 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.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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: 04.037.912.3, tfna lock drive.Lot number: 67p5492.Two pieces were scrapped, after being dropped.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheets met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: 52p7553.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree, tfna.Lot number: 34p5448.Production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Part number: 21127, timoagri16.00.Lot number: 49p9714.Inspection instruction met all inspection acceptance criteria.Certified test report 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.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.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the image.The image was reviewed, and the complaint condition can be confirmed.The tfna is broken.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.G1: manufacturing site name and address.

• Brand Name: 10MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12526094
• Report Number: 2939274-2021-05744
• Device Sequence Number: 19663663
• Product Code: HSB
• UDI-Device Identifier: 10886982096197
• UDI-Public: (01)10886982096197
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2021

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: 04.037.063S
• Device Catalogue Number: 04.037.063S
• Device Lot Number: 69P1867
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/24/2021; 09/30/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 09/27/2021; 10/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 100 -S; TFNA FENESTRATED HELICAL BLADE 100 -S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 93