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

Catalog Number 532.110VET

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

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 that during an orthopedic surgical procedure of a fracture on a canine it was observed that the small battery drive device "froze up" and did not do anything.It was reported that there was no delay in the procedure due to the event as an unspecified spare device was available and the procedure was successfully completed.There was no human patient involvement this device is for veterinary use only.There were no patient or user injuries reported.It was reported there was no 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

Upon further investigation it was found that the incorrect serial number ((b)(4)) was inadvertently entered into the initial medwatch report.The correct serial number ((b)(4)) has been entered into this medwatch report.Please note that the incorrect date of manufacture (dom) (mar 6, 2013) was inadvertently entered into the initial medwatch report.Upon further investigation the correct dom (jan 30, 2013) has been obtained and entered in this supplemental medwatch report.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The lot number was inadvertently documented as a serial number in the previous report.The lot number has been updated as 1061 and the serial number as na.The actual device was returned for evaluation.(b)(4) evaluated the device and the reported condition that the device does not work at all/frozen was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the unit ran but made an unusual noise from loose components inside, and the triggers were sticky.It was further observed that the motor was loose, one of the motor¿s magnets was missing, and the electric control unit (ecu) was damaged.The assignable root cause was determined to be due to wear from normal use over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE II VET SALE
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5613190
• MDR Text Key: 44617656
• Report Number: 8030965-2016-13467
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.110VET
• Device Lot Number: 1061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1