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-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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
Synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the connecting screw between a tibial nail and insertion handle for titanium cannulated tibial nail cross-threaded during disassembly.The hex shaft and wrench was used to apply enough force to disconnect the nail from the connecting screw.The procedure was completed successfully with a delay of approximately 15 minutes.Patient outcome was not provided.Concomitant devices reported: 9mm cannulated tibial nail-ex 330mm (04.004.346s, lot 7228397, quantity 1), insertion handle for titanium cannulated tibia nail (part number unknown, lot number unknown, quantity 1).This report is for one (1) 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: 7822303
• Report Number: 2939274-2018-53507
• Device Sequence Number: 1293608
• Product Code: FZX
• UDI-Device Identifier: 10886982067166
• UDI-Public: (01)10886982067166
• 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): 07/04/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1