MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM GUIDE WIRE 400MM; MISC ORTHO SURGICAL INSTR

Catalog Number 357.399

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

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.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 that the surgeon drilled into a trochanteric fixation nail advanced (tfna) while pre-drilling for tfna lag screw during an open reduction internal fixation (orif) of hip on (b)(6) 2018.The surgeon did so using the 6.0/9.0 mm cannulated stepped drill bit.This is because the surgeon inadvertently bent the 3.2mm guidewire upon adjusting the wire within the femoral head.The bent wire caused the drill to go off the central path and into the side of the nail.The guide wire was removed and replaced with a new one and the procedure was successfully completed with a delay of approximately two (2) minutes.There is no information provided regarding the status of the patient.Concomitant device (s) reported: 6.0/9.0 mm cannulated stepped drill bit (part # 03.037.102, unknown lot #, qty # 1), unknown tfna nail (unknown part and lot number, quantity #1).This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.2MM GUIDE WIRE 400MM
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7341877
• MDR Text Key: 102735270
• Report Number: 2939274-2018-51074
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982196248
• UDI-Public: (01)10886982196248(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/13/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 357.399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR