MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE HEXAGONAL SCREWDRIVER Ø5 COATED

Catalog Number	357.417
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: 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
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the staff discovered the black shaft of the 5.0mm flexible screwdriver from the tfn locking set is kinked and no longer works properly to tighten the shim in place nor remove the helical blade coupling screw.The procedure was successfully completed without delay.There were no patient consequences.Concomitant device reported: unknown insertion instruments (part# unknown, lot# unknown, quantity 1), unknown insertion instruments: connecting/coupling screw (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: FLEXIBLE HEXAGONAL SCREWDRIVER Ø5 COATED
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10080656
• Report Number: 2939274-2020-02487
• Device Sequence Number: 11725505
• Product Code: HXX
• UDI-Device Identifier: 07611819351738
• UDI-Public: (01)07611819351738
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2020

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 Catalogue Number: 357.417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1