MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM GUIDE WIRE 410MM

Model Number	292.655
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: visual inspection: the 1.6mm guide wire 410mm (p/n: 292.655, lot number: 9220291) was received at us cq.Visual inspection of the complaint device showed that it was bent in the middle.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: shaft diameter = 1.6 +0/-0.1 mm.Measured dimensions: shaft diameter = 1.56mm, conforming.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device is bent.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: part: 292.655, lot: 9220291, manufacturing site: (b)(4), release to warehouse date: 21.Oct.2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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 two (2) 1.6mm guide wire 410mm do not function and one (1) locking bolt measuring device f/trochanteric fixation nails was broken during reverse logistics audit of returned device at millstone.There was no patient involvement.This is report 2 of 3 for (b)(4).

• Brand Name: 1.6MM GUIDE WIRE 410MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9643868
• Report Number: 2939274-2020-00524
• Device Sequence Number: 11262932
• Product Code: FZX
• UDI-Device Identifier: 10886982180780
• UDI-Public: (01)10886982180780
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 292.655
• Device Catalogue Number: 292.655
• Device Lot Number: 9220291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1