MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.028S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient age, date of birth, gender, and weight not available for reporting.Date when non-union began is unknown.Device is not expected to return.Device history record review: manufacturing location: (b)(4), manufacturing date: 31-jul-2015, expiration date: 30-jun-2025.Part #: 04.037.028s, lot#: 9864913 (sterile) - 10 mm/125 deg ti cann tfna 380 mm/right- sterile.Quantity 6.Inspection sheet for in-process/inspect dimensional/final met inspection acceptance criteria.Component parts reviewed: the 04.037.912.2 - lock prong 125 degree, tfna bp-55 lot - 9529795.The 04.037.912.4 - wave spring, shim ended bp-55 lot - 7722133.The 4.037.912.3 - tfna lock drive bp-58 lot - 9841103.The 21127 - raw material lot bp-80 lot - 7813438.Raw material received from (b)(4).Certified test report received from (b)(4), certificate of test for titanium received from (b)(4) and raw material receiving/putaway checklist meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(4), ethicon (abq), ¿sterility documentation was reviewed and determined to be conforming.¿ the investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent a right open reduction internal fixation (orif) of a proximal femur fracture using a trochanteric fixation nail - advance (tfna) on (b)(6) 2017.Postoperatively, a non-union was identified on a routine follow-up x-ray.Patient was asymptomatic (no complaints of pain or discomfort).The patient did not heal due to lateral cortex portion of the femur bone was missing because of the complex fracture pattern.The patient underwent a revision on (b)(6) 2018 and received a right total hip replacement.All the removed implants were intact.There were no issues during the revision and no surgical time delay.The patient status was stable.This is report 2 of 3 for (b)(4).

• Brand Name: 10MM/125 DEG TI CANN TFNA 380MM/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: 7440669
• Report Number: 2939274-2018-51808
• Device Sequence Number: 13766157
• Product Code: HSB
• UDI-Device Identifier: 10886982095862
• UDI-Public: (01)10886982095862
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 04.037.028S
• Device Catalogue Number: 04.037.028S
• Device Lot Number: 9864913
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention