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 Problems Mechanical Problem (1384); Difficult To Position (1467)

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

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 by (b)(6) that during an unspecified veterinary surgical procedure, it was observed the saw blade device was unable to be completely screwed into the adaptor of the attachment device.It was noted that it seems to stop just short and the blade wobbles.It was unknown if there was delay in the procedure due to the event, however, it was reported that there were unspecified spare devices available for use.There was no human patient involvement as this was a veterinary procedure.There were no patient or user injuries reported.It was reported there was no 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 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.

Manufacturer Narrative

(b)(4).It was documented in the initial medwatch report that the lot number was 1328-r.Upon further investigation it was determined that this number (1328-r) represents the serial number of the product used in the procedure.Section d4 has been updated to reflect this change.It was inadvertently documented in the previous supplemental report that the device was returned to the manufacturer on may 22, 2017.As per communication with affiliate the correct date was jun 7, 2017.Updated to reflect this change.If additional information should become available, a supplemental medwatch report will be submitted accordingly.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 device coupling tool side was not functioning and defective.It was noted that the thread in the tool coupling is defective.It was further determined that the device failed pretest for check the tool coupling, check the thread on the tool coupling side, and check status of development.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: 6554507
• MDR Text Key: 74753050
• Report Number: 8030965-2017-12238
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1328-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/02/2017; 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2010
• 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