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 Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 device just stopped working.It was reported that there was an hour delay in the procedure due to the event as an unspecified spare device was available for use to complete the procedure successfully.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 will be submitted accordingly.

Manufacturer Narrative

The date returned to manufacturer was documented as aug 14, 2017 on the initial report.This date has been updated to aug 30, 2017.Device evaluation: the device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and it was determined that bearing of the attachment device had seized, jammed, and was moving heavily.It was noted that the bearing was blocked.It was further determined that the device failed pretest for check frequency.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 report 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: 6820236
• MDR Text Key: 83641481
• Report Number: 8030965-2017-14604
• 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: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• 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: 100147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2014
• 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