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 Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer 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 ttibial plateau leveling osteotomy (tplo) surgical procedure on a canine, it was observed that the small battery drive device was making a grinding noise and would stop working.It was reported that the device would start working again after a few minutes of rest.It was reported that there was a 30 minute delay in the procedure due to the event and there was no spare device available for use.It was reported that the procedure was successfully completed.The reporter stated that this was the first use of the device and noted that the device sounded very different from last one the facility had.There was no human patient involvement as this was a veterinary procedure.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

The actual device was returned for evaluation.The small battery drive device was evaluated and the reported condition that the device stops during use and will start again after a few minutes of rest was confirmed.An assessment was performed and it was observed that the unit was found to be running intermittently.It was further observed that the unit failed off/ oscillation/ on switch mode function, the unit failed the function with the electric pen drive (epd)-console ¿ ran intermittently, and the electric motor was damaged ¿ intermittent rotation.It was determined that the electric motor's brushes were damaged due to excessive force during use.The assignable root cause was determined to be due to improper handling, which is user error/ misuse/ abuse.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.

• 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: 6992928
• MDR Text Key: 91958033
• Report Number: 8030965-2017-15947
• 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,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• 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: 2656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• 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