MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; GUIDE

Catalog Number	357.411
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of event 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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Canada reported that the insertion handle for trochanteric fixation nail is bent or damaged and does not allow the aiming arm to align with the hole in the nail.There were no fragments generated, and there are no missing pieces.The surgery was completed using the device, with no reported patient harm.Concomitant device reported: unknown tfn aiming arm (part # unknown, lot # unknown, quantity 1).This report is for one (1) insertion handle f/trochanteric fixation nails.This is report 1 of 1 for complaint (b)(4).

• Brand Name: INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7238358
• Report Number: 2939274-2018-50481
• Device Sequence Number: 1014578
• Product Code: FZX
• UDI-Device Identifier: 10886982196347
• UDI-Public: (01)10886982196347(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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 Catalogue Number: 357.411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1