MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE; GUIDE

Catalog Number	03.010.044
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 during implantation of the tibial nail and locking screws on (b)(6) 2018, the nail would not disconnect from the standard insertion handle.The ball hex screwdriver was bent in a 90-degree angle to get enough leverage to release the cannulated connecting screw.After inspection, both cannulated connecting screws were showing signs of discrepancies.There was a surgical delay of ten minutes.Surgery was successfully completed.Patient outcome is unknown.Concomitant device reported: ball hex screwdriver 8mm (part: 03.010.092, lot: unknown, quantity: 1).This report is for a cannulated connecting screw for standard insertion handle.This is report 1 of 1 for (b)(4).

• Brand Name: CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7553158
• Report Number: 2939274-2018-52336
• Device Sequence Number: 1186622
• Product Code: FZX
• UDI-Device Identifier: 10886982067166
• UDI-Public: (01)10886982067166
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 03.010.044
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1