MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE; GUIDE

Model Number	03.124.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2019 during an unknown surgery two (2) interlocking bolts for a percutaneous insertion handle would no longer screw into the plate.It is unknown if there was a procedure or patient involvement.Concomitant device reported: unknown plate (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 1.6mm interlocking bolt for percutaneous insertion handle.This is report 1 of 2 for (b)(4).

• Brand Name: 1.6MM INTERLOCKING BOLT FOR PERCUTANEOUS 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: 9429372
• Report Number: 2939274-2019-62541
• Device Sequence Number: 479633
• Product Code: FZX
• UDI-Device Identifier: 10886982074997
• UDI-Public: (01)10886982074997
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/18/2019

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: 03.124.005
• Device Catalogue Number: 03.124.005
• Device Lot Number: 9102357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1