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

Catalog Number 532.110

Device Problem Complete Loss of Power (4015)

Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: battery devices, (b)(6) 2020.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 that during the middle of an unspecified orthopedic veterinary surgery, it was observed that the small battery drive device stopped working.According to the reporter, the battery pack was taken out of the drill and put back in, then it worked again for a few seconds.The reporter stated that the batteries worked with another drill, and both battery packs were brand new, ¿(within the last month)." the reporter indicated that the device was recently sent for repairs for a similar incident.It was reported that there was approximately ten-minutes delay to the surgical procedure.It was not reported if a spare device was available for use.There was no human patient involvement as the device was used in 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 report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and determined that the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the trigger was sticky.It was further determined that the device failed pretest for check for sticky triggers.The assignable root cause was determined to be due to component failure from normal wear.

• Brand Name: SMALL BATTERY DRIVE 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: 10733491
• MDR Text Key: 213008386
• Report Number: 8030965-2020-08080
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819408357
• UDI-Public: 07611819408357
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

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: 532.110
• Device Lot Number: 1392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1