MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE; ROD, FIXATION INTRAMEDULLARY

Model Number	04.037.163S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Part returned.(b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 or Problem Description
It was reported that on (b)(6) 2019, the patient underwent trochanteric femoral nail (tfn) revision surgery due to severe pain at the site of breakage.The trochanteric femoral nail-advanced (tfna) devices were originally implanted on (b)(6) 2018, for a peri trochanteric fracture using a nail size of 11 x 420 left with a 105 screw.There was additional medical intervention performed to the patient having prescriptions and physical therapy.Fragments generated from the broken device and was difficult to remove due to broken nail in two pieces.It was unknown if there was a surgical delay.Procedure outcome was unknown.There was a patient consequence.Concomitant devices reported: tfna fenestrated screw (part #: 04.038.205, lot #: h452577, quantity #: 1), unknown locking screws (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is 1 of 1 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.A device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 27-mar-2018, expiration date: 28-feb-2028, part number: 04.037.163s, 11mm/130 deg ti cann tfna 420mm / left ¿ sterile, lot number: h597038 (sterile), lot quantity: (b)(4).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 parts reviewed: part number: 04.037.942.2, lock prong, 130 degree, tfna bp55, lot number: l634505, lot quantity: (b)(4).Purchased finished goods travelers met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended bp55, lot number: h529578, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive bp58, lot number: h556414, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet ns062925 rev e met all inspection acceptance criteria.Part number: 21127, timoagri16.00 bp80, lot number: h381834, lot quantity: (b)(4).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 conducted.Visual inspection: 11mm/130 deg ti cann tfna 420mm/left ¿ sterile was received at cq.Upon visual inspection at cq, it is observed that the nail is broken at its proximal head part.There are some discolored spots on the surface of the device.Thus, the reported complaint is confirmed.The received condition does agree with the complaint description.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Document/ specification review: the relevant drawing(s) was reviewed; no design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, and document specification review of the received device was performed at cq.The complaint is confirmed.A definitive root cause could not be determined.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
Event or Problem Description
Further it was reported that there was metallosis in the surrounding bone.

• Brand Name: 11MM/130 DEG TI CANN TFNA 420MM/LEFT - 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: 8781398
• Report Number: 2939274-2019-59127
• Device Sequence Number: 11235266
• Product Code: HSB
• UDI-Device Identifier: 10886982096715
• UDI-Public: (01)10886982096715
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 04.037.163S
• Device Catalogue Number: 04.037.163S
• Device Lot Number: H597038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR