MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS QUICK COUPLING FOR DRILL BITS F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.750

Device Problem Failure to Discharge (1169)

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

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative:the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 total joint ankle replacement surgical procedure, it was observed that the quick coupling device was not working.There were no delays to the surgical procedure as spare devices were available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.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.Reliability engineering evaluated the device and observed it wasn¿t working and it missing a component (cone sleeve) and could not be fully tested.Therefore, the reported condition was confirmed.The assignable root cause was determined to be to loctite degradation and/or improper handling and care.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QUICK COUPLING FOR DRILL BITS F/BPL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5378463
• MDR Text Key: 36738904
• Report Number: 8030965-2016-10350
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.750
• Device Lot Number: 3159185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1