MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COLIBRI II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.101

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

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.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the small battery drive device suddenly stopped working.It was not reported if there were any delays in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.There were no reports of any 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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the small battery drive device would not run and the motor was damaged.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COLIBRI II
• 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: 9086273
• MDR Text Key: 159151035
• Report Number: 8030965-2019-68368
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819408319
• UDI-Public: 7611819408319
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1