MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.026S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) 2019, the patient underwent a removal surgery due to a blade subtrochanteric femur non-union.The patient had the initial surgery where patient came in with a broken leg that was implanted with a trochanteric fixation nail advanced (tfna) on (b)(6) 2018.The tfna was broken at the pole in the proximal end of the nail.There were two (2) distal locking screws 5.0 x 40 mm in length, one (1) of those was broken and the nail was removed.The said fracture site of the non-union subtrochanteric was revived using bone graft and vivigen.They put a new nail end with the same side implants so they nailed the non-union.There was some delay in surgery given the fact that the original nail was broken.Patient status was unknown.Concomitant devices reported: nail distal locking screw (part/lot unknown, quantity 1); tfna fenestrated screw 90mm - sterile (part: 04.038.190s, lot: h666258, quantity: 1).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.Part 04.037.026s, lot h506538: manufacturing location: monument.Manufacturing date: november 28, 2017.Expiration date: october 31, 2027.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.A product investigation was completed: visual inspection performed identified the nail broke at the proximal hole.The break is jagged and oblique.Both nail portions were returned.No new issues were identified.The received condition does agree with the complaint description for broken and is confirmed.The cause of the issue could not be determined to be use error, misuse/abuse, noncompliance, postoperative trauma.The dimensional inspection showed the relevant dimensions were conforming.The relevant drawings were reviewed as part of this investigation; no design issues contributing to relevant complaint condition were identified.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Material certification and certificate of conformance and quality history card were reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.A definitive assignable root cause for the nail breaking postoperatively could not be determined based on the provided information.During this investigation no product design or manufacturing issues were observed 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
Updated concomitant device: locking screw (part 04.005.530, lot unknown, quantity 1).

• Brand Name: 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8374626
• Report Number: 2939274-2019-56696
• Device Sequence Number: 10814689
• Product Code: HSB
• UDI-Device Identifier: 10886982095848
• UDI-Public: (01)10886982095848
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 04.037.026S
• Device Catalogue Number: 04.037.026S
• Device Lot Number: H506538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR