MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS OSCILLATING SAW ATCH, LARGE, WITH KEY; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 532.026VET

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 veterinary tibial plateau leveling osteotomy repair surgery, it was observed that the saw attachment device was not locking properly while in use.As a result, there was a slight delay in the surgical procedure while the technician retrieved a spare device.It was reported that the case was successfully completed.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

Correction: the date the device was returned to the manufacturer was updated to june 15, 2017.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the housing was loose (adhesive between the housing and the coupling was loose) and the frequency could not be measured.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.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 POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6581348
• MDR Text Key: 75623248
• Report Number: 8030965-2017-12486
• Device Sequence Number: 1
• Product Code: GFA
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.026VET
• Device Lot Number: 1139-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1