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 01/09/2019

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.

Event Description

It was reported that during an unspecified veterinary surgical procedure it was observed that the oscillating saw attachment with key device was running sluggishly.During in-house engineering evaluation it was observed that the unit was running slow and then sped up (the speed was not consistent), and the attachment was getting hot.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

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.Additional narrative: the date returned to manufacturer was documented as january 21, 2019 on the initial report.This date has been updated to january 28, 2019.The manufacturing site name was documented as oberdorf synthes produktions gmbh (oberdorf) in the initial report.This has been updated to synthes produktions gmbh (waldenburg).Please note that the contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the bearings of the attachment device were worn out.It was noted that the needle bearing was defective.It was further determined that the device failed pretest for check oscillation frequency.Therefore, the reported condition 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: 8305946
• MDR Text Key: 135376620
• Report Number: 8030965-2019-60425
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 7611819996069
• UDI-Public: (01)7611819996069(11)130705
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• 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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1