MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.010VET

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4). The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, 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 a veterinary tibial plateau leveling osteotomy (tplo) surgery, it was observed that the small battery drive device had intermittent operation. There was a sixty minute delay to the surgical procedure. A spare device was available to complete the surgery. 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

The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was not confirmed. Therefore, an assignable root cause was not determined. However, during evaluation, it was determined that the device did not work at all and was not functional. It was further determined that the coupling head was worn. It was observed that the electric motor was damaged, the device had rough rotation and the magnets came off the main gear. It was further determined that the contacts were corroded on the electronic control unit and the gear parts and seals were worn. It was determined that there was corrosion on the internal components. It was further determined that these issues were consistent with component wear. The assignable root cause was determined to be due to wear from normal use over time. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMALL BATTERY DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6435553
• MDR Text Key: 70907616
• Report Number: 8030965-2017-11459
• Device Sequence Number: 1
• Product Code: HWE
• 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: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 532.010VET
• Device Lot Number: 003962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage