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 Vibration (1674)

Patient Problem Not Applicable (3189)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi ¿ (b)(4).

Event Description

It was reported from (b)(6) that the oscillating saw attachment device could be removed even when locked, the saw blade was vibrating more than usual, the connection part of the saw blade device was scratched, and the etching of the lock was out of place.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no human patient involvement as this device is intended for veterinary use only.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2019.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.Concomitant medical products: please note that the date returned to manufacturer was reported as october 25, 2019 in the previous medwatch report.The date has been updated to october 24, 2019.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the attachment device was cracked.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to component failure.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: 9275925
• MDR Text Key: 196997632
• Report Number: 8030965-2019-69925
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/24/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1