MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.021

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

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

It was reported that during a toe amputation surgery on an animal, it was observed that the sagittal saw attachment device was broken and would not move the saw device back and forth. There were no delays to the surgical procedure as a spare device was available to complete the surgery successfully. There was no human patient involvement as the device was used in 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. Reliability engineering evaluated the device and the reported condition was confirmed. A visual and functional assessment was performed on the device which found that the device did not function, would not oscillate and was frozen. During service/repair, it was determined that the needle bearings and housing were corroded. The assignable root cause was determined to be due to improper cleaning methods, which is user error/misuse/abuse. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: SAGITTAL SAW ATTACHMENT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7327059
• MDR Text Key: 102225575
• Report Number: 8030965-2018-51876
• Device Sequence Number: 1
• Product Code: HWE
• 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: 02/20/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 532.021
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No