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 Problems Device Stops Intermittently (1599); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The actual device was returned for evaluation. Reliability engineering evaluated the device and identified no failure. It was determined that the device passed all tests. Therefore, the reported condition was not confirmed. An assignable root cause was not determined. However, during evaluation, it was determined that there was corrosion on electric motor due to improper cleaning/care. It was determined that this was a non-failure. 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 tibial plateau leveling osteotomy on a canine, it was observed that the small battery drive device had intermittent operation for the last few surgeries and finally resulted in unresponsiveness in the final surgery. It was reported that the device was not working regardless of the battery or casing. It was not reported if there was a delay in there were any delays in the surgical procedure. It was a reported that a spare device was available for use. It was reported that the surgery was completed successfully. 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 report will be submitted accordingly.

• 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: 6683823
• MDR Text Key: 78908476
• Report Number: 8030965-2017-13373
• 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: user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 532.010VET
• Device Lot Number: 004676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage