MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 532.110

Device Problem Intermittent Loss of Power (4016)

Patient Problem Not Applicable (3189)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, 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 an unspecified veterinary surgical procedure, it was observed that the small battery drive device had no power and once removed from surgery they tested it with other batteries and it slowly started working again.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was no human patient involvement as this was a veterinary procedure.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 will be submitted accordingly.

Manufacturer Narrative

Corrected data, the date the device was returned to the manufacturer was reported as december 24, 2019 in the initial report and has been updated to december 23, 2019.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device failed the sticky speed trigger assessment, the device stopped working after running for a little bit, the motor was damaged, an unknown liquid was found on the electronic control unit and other components had water marks and contaminated grease on them.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9528440
• MDR Text Key: 190678774
• Report Number: 8030965-2019-71334
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10886982241191
• UDI-Public: 10886982241191
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• 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