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 Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

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.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 a veterinary tibial plateau leveling osteotomy surgery, it was observed that the small battery drive device and the oscillating saw with key had low power while being used together.It was not reported if there were any delays in the procedure.It was reported that they were able to successfully complete the surgery with the same devices.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 report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.During repair, it was determined that the bearing on the device was seized, jammed, and moving heavily.It was further determined that the needle bearings were blocked.It was also determined that the device failed pre-test for check oscillation frequency.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.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
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7311036
• MDR Text Key: 101622194
• Report Number: 8030965-2018-51657
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 7611819996069
• UDI-Public: (01)7611819996069(11)160427(10)100452
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.026
• Device Lot Number: 100452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1