MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BEARING SLEEVE, 15CM CURVED; DRILLS, BURRS, TREPHINES & ACCESSORIES - BEARING SLEEVE

Catalog Number	MA-15C
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the nose cone of the sleeve was bent, damaged and heavily worn and the heat on the sleeve¿s nose cone was higher than the recommended specification.Also, the cutting tool was heavily bent causing overheating to a degree which caused it to break.According to the investigator, the sleeve should not have been used as it was heavily bent and worn.The device also failed pretest visual assessment and max temperature of sleeve.Therefore, the reported condition was confirmed.The assignable root cause was traced to component failure.A device history review was performed, and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Concomitant med products and therapy dates: cutter device, driver device (b)(6) 2019).Initial reporter's full name was not provided.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.Udi: (b)(4).
Event or Problem Description
This is report 2 of 3 for the same event.It was reported from (b)(6) that during an endoscopic lumbar laminectomy mepd mild surgical procedure for a lumbar spinal canal stenosis (arthroscopic ablation for arch of lumbar vertebra) it was observed that after 3 to 5 minutes of cutting out bone with a minimal access driver device, bearing sleeve device, and cutter device, the handle of the device had become quite heated, and the bar of the cutting burr device immediately broke off.It was reported that the device drove at 80,000 rotations per minute (rpm) during the ablation.It was reported that there was a five-minute delay in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.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.

• Brand Name: BEARING SLEEVE, 15CM CURVED
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - BEARING SLEEVE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9443928
• Report Number: 1045834-2019-55082
• Device Sequence Number: 2256124
• Product Code: HBE
• UDI-Device Identifier: 00845384004325
• UDI-Public: 845384004325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: MA-15C
• Device Lot Number: E043044704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1