MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; WIRE, SURGICAL

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.One (1) unknown guide/compression/k-wires: trauma.Part and lot number are unknown; udi 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 manufacture date is unknown.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 Description

It was reported on the afternoon of (b)(6) 2017, a drill bit broke intra-operatively during a blade insertion for a tfn-advanced¿ proximal femoral nailing system (tfna) procedure.While the surgeon was drilling to put in the tfna blade, he used the blunt end of the guide pin for the step drill to insert the drill bit and ensure nothing would be punctured.Upon insertion, the tip drill bit broke and the guide pin was bent.Nothing was embedded in the bone.Another drill bit and guide pin was used to complete the surgery.There was a five (5) minute delay as new prats had to be retrieved.Surgery was completed successfully and patient status was reported as stable.Concomitant devices reported: unknown step drill bit (part# unknown, lot# unknown, quantity 1).This report is for 1 unknown guide/compression/k-wires: trauma.This is report 2 of 2 for (b)(4).

• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7061229
• MDR Text Key: 94197166
• Report Number: 2939274-2017-50042
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/27/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR