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 Detachment of Device or Device Component (2907)

Patient Problem Not Applicable (3189)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that after a tibial-plateau-leveling osteotomy (tplo) veterinary surgical procedure, it was observed that the oscillating saw attachment device broke into three parts during use.According to the reporter, the problem was solved by swinging the saw by hand.This event did not occur during surgery.There was no human patient involvement as this device is for veterinary use only.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2018.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.H10: the actual device was returned for evaluation.The device was evaluated and it was determined that the device had a broken saw blade guidance on the left side and the saw blade fixation did not work well as the thread caused the screw to jam.The device also failed pretest for general condition, check the saw blade coupling and check the thread on the saw blade coupling.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to user error.Additionally, a review of the device history was performed and no non-conformances were detected related to the reported condition.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: 8111627
• MDR Text Key: 128738030
• Report Number: 8030965-2018-58544
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 7611819996069
• UDI-Public: (01)7611819996069(11)180329
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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: 02/08/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1