MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC OSCILLATING SAW ATCH, LARGE, WITH KEY; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 532.026

Device Problem Overheating of Device (1437)

Patient Problem Not Applicable (3189)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant med products and therapy dates: handpiece device, ((b)(6) 2019).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.Udi: (b)(4).

Event Description

It was reported that during a tibial-plateau-leveling osteotomy (tplo) surgical procedure it was observed that the oscillating saw attachment device would slow down, lose power, cause the handpiece device to overheat, and would then stop working.It was reported that there was a 15 minute delay in the procedure due to the event.It was reported that there was an unspecified spare device available for use.It was reported that it was originally thought that the hand piece was the cause when the event occurred in a separate procedure, but when the loaner handpiece device was used in this procedure the same issue occurred, and it was discovered that the attachment device was the cause.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 will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the bearing of the attachment device had seized.I was noted that the bearing was blocked.It was further determined that the device failed pretest for check oscillation frequency.Therefore, the reported condition that the unit runs slow and then stops was confirmed.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 will be submitted accordingly.

• Brand Name: OSCILLATING SAW ATCH, LARGE, WITH KEY
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8821383
• MDR Text Key: 152042972
• Report Number: 8030965-2019-66496
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07611819996069
• UDI-Public: 7611819996069
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1