MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COLIBRI II HANDPIECE; 7611819408319

Catalog Number 532.101

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

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 additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the handpiece device suddenly stopped working.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no 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 will be submitted accordingly.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COLIBRI II HANDPIECE
• Type of Device: 7611819408319
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7620992
• MDR Text Key: 112229616
• Report Number: 8030965-2018-54449
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819408319
• UDI-Public: (01)7611819408319(11)140509
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/26/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1