MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.012

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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 during an unknown procedure on (b)(6) 2018, the surgical technician and surgical assistant had difficulty putting the tfn-advanced proximal femoral nailing system (tfna) nail onto the complete radiolucent insertion handle.The tfna nail did not easily connect onto the insertion handle.No known surgical outcome and surgical delay.Patient outcome is unknown.Concomitant devices: 11mm/130 deg ti cann tfna 170mm ¿ sterile (part: 04.037.142s, lot: unknown, quantity: 1).This report is for a complete radiolucent insertion handle.This is report 1 of 1 for (b)(4).

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.Subject device has been received and is currently in the evaluation process.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.A device history record (dhr) review was conducted for part no.: 03.037.012, lot no.: 9426238: manufacturing location: haegendorf, release to warehouse date: 21.May.2015: no non-conformance reports (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.A product investigation was conducted.Visual inspection performed at customer quality (cq) observed post manufacturing damage to the distal coupling that mates with implant nails.The ledge is malformed and dented.This post manufacturing damage would contribute to the reported condition of difficulty mating with implant nail.Therefore, the condition of the returned device confirms the reported complaint condition.A functional test was not able to be performed at cq because the nail was not returned.However, the damage on the handle would cause the reported condition.The returned device was manufactured in may 2015 and is over 3 years old.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.Relevant drawings were reviewed during this investigation.The 03.037.012 complete radiolucent insertion handle fastens to the trochanteric fixation nail by matching the geometry of the handle to the nail and connect the insertion handle.The nail should click-in and self retain to the handle, the connecting screw is then inserted into the handle and threaded into the proximal portion of the nail per the tfnadvanced proximal femoral nailing system technique guide.No product design issues or discrepancies were observed.An accurate dimensional inspection of features relevant to this complaint could not be obtained at cq due to the post manufacturing damage.While no definitive root cause could be determined it is possible that any unintended forces encountered by the device during its usage or handling could have led to the complaint condition.This complaint is confirmed however no product design issues or manufacturing discrepancies were identified during this investigation.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.

• Brand Name: COMPLETE RADIOLUCENT INSERTION HANDLE
• 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: 7548434
• MDR Text Key: 109368159
• Report Number: 2939274-2018-52324
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070289
• UDI-Public: (01)10886982070289
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.012
• Device Catalogue Number: 03.037.012
• Device Lot Number: 9426238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1