MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.5MM DMND MTCH HEAD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	8450107035D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device received but awaiting evaluation results.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke in the attachment.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The bur reported involved in this event was returned for evaluation.On receipt of the bur the bur was observed to be broken.The bur was evaluated by product engineering who observed; wear was noted on the drill shank.The location of the wear is at the attachment front bearing location.It is likely that the attachment front bearing was failing during use.This would have restricted rotation which would increase localized wear on the shank of the bur resulting in the break.This bur broke due to attachment front bearing failure.As a result the bur is considered concomitant to the attachment in this case.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke in the attachment.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 3.5MM DMND MTCH HEAD, 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9745660
• Report Number: 0001811755-2020-00544
• Device Sequence Number: 10941213
• Product Code: HBE
• UDI-Device Identifier: 07613327097078
• UDI-Public: 07613327097078
• Combination Product (Y/N): N
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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 Expiration Date: 11/01/2020
• Device Model Number: 8450107035D
• Device Catalogue Number: 8450107035D
• Device Lot Number: 15334017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1