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 Code Available (3191)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided for reporting.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 a patient underwent a procedure to repair an femoral fracture of hip on (b)(6) 2017 using the synthes trochanteric fixation nail advanced (tfna) system.During the procedure, after the helical blade and tfna nail were initially implanted, x-rays were taken and showed that the helical blade had been implanted anterior to the nail.The surgeon then removed the nail and the helical blade and re-attached the nail to the aiming arm and it was noted that all of the devices lined up as intended.The nail was then re-inserted; however, when the surgeon was reaming for the helical blade, the reamer traveled anterior to the nail and "nicked" the nail; it was clarified that the blade made contact with the nail and no fragments were generated.Upon inspecting the synthes 3.2mm guide wire, the surgeon noted that the device was bent and would have contributed to the misalignment of the other devices.Both the implants were removed and there was a ten (10) minute surgical delay while the hospital staff obtained another nail and a longer helical blade to complete the surgery.The procedure was successfully completed and the patient was reported to be in stable condition.Concomitant devices reported: tfna nail (part# unknown, lot# unknown, qty.1); helical blade (part# unknown, lot# unknown, qty.1); synthes aiming arm (part# unknown, lot# unknown, qty.1); reamer (part# unknown, lot# unknown, qty.1).This report is for one (1) 3.2mm guide wire 400mm.(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 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7169471
• MDR Text Key: 96587538
• Report Number: 2939274-2018-50098
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982196248
• UDI-Public: (01)10886982196248(10)LOT#UNKNOWN
• 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: 12/08/2017

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?: No
• 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: 12/08/2017
• Initial Date FDA Received: 01/05/2018
• 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