MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.042S

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.It is unknown when the event occurred.Complainant part has not been returned for manufacturer review/investigation.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 Description

It was reported that a broken trochanteric fixation nail advanced (tfna) was removed on (b)(6) 2018.After the tfna construct was removed the surgeon performed a hemi-hip arthroplasty.The original surgery was done on an unknown date approximately six (6) months ago.Concomitant devices reported: 95mm tfna lag screw (part # 04.038.095, lot # unknown, quantity # 1).Screws: locking: trauma (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) devices.(b)(4).This report is for a nail.

Manufacturer Narrative

A product investigation was performed.The returned x-ray was reviewed and the complaint condition was able to be confirmed as the nail was found to be broken at the head element oblique hole.Based on the complaint description no definitive root cause was able to be identified.The device was not available for return, as such an as received condition, drawing review and dimensional analysis are not applicable for this complaint.A device history review, including material and hardness reviews, was performed for the returned implant¿s lot number and no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Unrelated nc nr¿25722 was generated during final inspection for burrs on the oblique hole and m6 thread; this nc is not related to the observed failure of broken postoperatively.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.

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.Device was used for treatment, not diagnosis.Device history record review manufacturing location: monument, manufacturing date: 26-jul-2016, expiration date: 30-jun-2026.Part #: 04.037.042s, lot#: h149523 (sterile) - 10mm/130 deg ti cann tfna 170mm - sterile.Quantity 6.Component parts reviewed: part 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot - l009147.Part 04.037.912.4 - wave spring, shim ended bp-55 lot - h089439.Part 04.037.912.3 - tfna lock drive bp-58 lot - h135012.Part 21127 - raw material lot bp-80 lot - h062002.Raw material for titanium received from metalwerks pmd, certificate of analysis for titanium received from metalwerks meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for in-process/inspect dimensional/final and inspection sheet for tfna assembly inspection met inspection acceptance criteria.Nc nr-25722 was initiated at qa final inspection.Created on 12/16/2015 for "burrs are being found at final inspection at the oblique hole and at the m6 thread on tfna nails" which is not relevant to complaint condition of " broken trochanteric fixation nail advanced (tfna)".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.Scn no: (b)(4) ethicon (abq), ¿sterility documentation was reviewed and determined to be conforming.¿ if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 10MM/130 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7338792
• MDR Text Key: 102384686
• Report Number: 2939274-2018-51048
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982095985
• UDI-Public: (01)10886982095985(10)H149523
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.042S
• Device Catalogue Number: 04.037.042S
• Device Lot Number: H149523
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 57