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

Catalog Number 532.022

Device Problems Detachment Of Device Component (1104); Device Contamination with Chemical or Other Material (2944); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.The quick coupling device was evaluated and the reported condition that black debris is coming out while in use, and sounds like something is catching on the pin when it is inserted into the device was confirmed.An assessment was performed and it was observed that a black substance was leaking from the device, the bearing was damaged with corrosion and rough rotation, the clamps were corroded, and the o-ring was worn.It was further determined that the device failed pretest for check for smooth running.The assignable root cause was determined to be due to improper cleaning and maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during a tibial plateau leveling osteotomy (tplo) surgical procedure on a canine it was observed that black debris was coming out of the quick coupling device and it sounded like something was catching on the pin when it was inserted into the device.It was reported there was no delay and the surgeon wiped off the device and kept using it to complete the surgery successfully.It was reported nothing fell into the patient.There was no human patient involvement as this was a veterinary procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however it was reported that the event occurred in (b)(6) 2017.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: QUICK COUPLING FOR K-WIRES
• 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
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7083016
• MDR Text Key: 93866739
• Report Number: 8030965-2017-50304
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819107199
• UDI-Public: (01)07611819107199(11)101207
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.022
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Date Device Manufactured: 12/07/2010
• 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