MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS; GAUGE,DEPTH

Model Number 03.010.428

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2020

Event Type  malfunction  

Manufacturer Narrative

Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 during a tibial nail insertion on (b)(6) 2020, the depth gauge for locking screws has lost its integrity.It was mentioned that the reported device was bent so many times that it no longer reads the correct length for screw.The procedure was successfully completed with the use of another depth gauge.There was a 10 minutes surgical delay.Patient status is unknown.Concomitant device reported: unknown locking screw (part # unknown, lot # unknown, quantity unknown) unknown tibial nail (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is for (1) advanced appl inner shaft.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10864438
• MDR Text Key: 217452549
• Report Number: 2939274-2020-05221
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982068699
• UDI-Public: (01)10886982068699
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.428
• Device Catalogue Number: 03.010.428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: TIBIAL.; UNK - SCREWS: LOCKING.