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

Catalog Number 532.110VET

Device Problems Overheating of Device (1437); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

Udi: (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

This is report 1 of 2 for the same event: it was reported that during an unspecified veterinary surgical procedure, it was discovered that the small battery drive device was working inconsistently.It was further reported that it was difficult to insert and attach the oscillating saw attachment device to the handpiece device.According to the reporter, when the device was cooled, it sometimes worked.However, the device did not work when it became hot.It was further reported that the device seemed to have a connection issue.The device worked sometimes and then it stopped working.The reporter stated that the issue was dependent on the way the device was being held and if it was hot or not.There was minimal delay to the surgical procedure.However, the duration of the delay was not specified.It was not reported if spare devices were available for use.There was no human patient involvement as the devices were used in a veterinary procedure.It was not reported if there were any 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 confirmed.It was determined that the unit was found not to be working.The unit was being used with oscillating saw attachment device.The two units were tested together and the oscillating saw attachment device was found to be working as expected.A visual and functional assessment was performed which found that the unit was not working.During repair, it was observed that the motor was damaged and did not rotate (no ampere).It was determined that the bearings were corroded and the coupling head was worn.It was further determined that the issues were consistent with normal 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 II VET SALE
• 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: 6823657
• MDR Text Key: 84002852
• Report Number: 8030965-2017-14546
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• 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: 1881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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