MAUDE Adverse Event Report: SYNTHES OBERDORF SMALL BATTERY DRIVE 12V BATTERY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.003VET

Device Problem Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).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 a veterinary tibial tuberosity advancement (tta) surgery on a canine, it was observed that the battery device was not holding a charge.There were no delays to the surgical procedure as a spare device was available to complete the surgery successfully.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.The exact date of the event was unknown; however, the reporter stated that the event occurred during the month of (b)(6) 2017.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 has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device.A functional assessment was performed and the device passed all manufacturing specifications.The reported condition was not duplicated or confirmed.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMALL BATTERY DRIVE 12V BATTERY
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6416827
• MDR Text Key: 70330754
• Report Number: 8030965-2017-11337
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.003VET
• Device Lot Number: D150707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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