MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM; MISC ORTHO SURGICAL INSTR

Model Number	03.010.487
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part: 03.010.487; lot: 8806955; manufacturing site: (b)(4); release to warehouse date: 29.July 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, during an unknown procedure, the targeting arm for the retrograde/antegrade femoral nail (rafn) was causing the locking screws to miss the nail.There was a surgical delay of ten (10) minutes.Procedure was successfully completed.Patient outcome is unknown.  concomitant devices reported: unknown nail (part# unknown, lot# unknown, quantity 1), unknown locking screws (part # unknown, lot # unknown, quantity# unknown).  this report is for one (1) radiolucent insertion handle for expert nails/175mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8545894
• Report Number: 2939274-2019-57621
• Device Sequence Number: 2443807
• Product Code: LXH
• UDI-Device Identifier: 10886982069054
• UDI-Public: (01)10886982069054
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.010.487
• Device Catalogue Number: 03.010.487
• Device Lot Number: 8806955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1