MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC LARGE QUICK COUPLING FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.213

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from (b)(6) that during a tfn (titanium trochanteric fixation nail)-advanced proximal femoral nailing system (tfna) surgical procedure, it was observed that the quick coupling attachment device would not hold the reamers.It was further reported that the problem occurred when the spinning drill bit device came in contact with the bone, the drill bit device would not spin and ream.There were no delays to the surgical procedure as a spare device was available to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.The device was evaluated and the reported condition was confirmed.A visual and functional assessment was performed which found that the device would not hold the cutter device in place (failed tool coupling test).During service/repair, it was determined that the unit's coupling shaft couple was damaged.It was determined that other components were worn and corroded.The assignable root cause was determined to be due to normal wear.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: LARGE QUICK COUPLING FOR TRS
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7320060
• MDR Text Key: 101790595
• Report Number: 8030965-2018-51795
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819977914
• UDI-Public: (01)07611819977914(11)170118
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.213
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1