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

Catalog Number 532.101

Device Problem Device Stops Intermittently (1599)

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

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Reporter's phone number was not provided.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 the small battery drive device would not start, and when it would start, it would stop working and shut off.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay in a planned surgical procedure, or if a spare device was available for use.It was not reported if there was patient involvement.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 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the motor seized, jammed, and was moving heavily.It was noted that the device had a defective motor and switching function.It was further determined that the device failed pretest for check the off/oscillation/on switch mode function.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COLIBRI II HANDPIECE
• 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: 7651398
• MDR Text Key: 112850474
• Report Number: 8030965-2018-54710
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819408319
• UDI-Public: (01)7611819408319(11)160418
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1