MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM K-WIRE INSERT; GUIDE

Model Number	324.084
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: (b)(6).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2020, the patient underwent an unknown procedure.During the procedure, while the surgeon attempted to place a kirschner wire through the kirschner wire insert within the threaded drill guide, the kirschner wire was unable to pass through the guide.After the case, the device was inspected, and it was discovered the kirschner wire insert was bent and was no longer usable.The procedure was successfully completed with no surgical delay.There was no patient consequence.Concomitant device reported: unknown kirschner wire (part# unknown, lot# unknown, quantity# 1); unknown drill guide (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: 1.25MM K-WIRE INSERT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10133394
• Report Number: 2939274-2020-02721
• Device Sequence Number: 11490850
• Product Code: FZX
• UDI-Device Identifier: 10886982191113
• UDI-Public: (01)10886982191113
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: 324.084
• Device Catalogue Number: 324.084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: GUIDE