MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM MTCH HD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8450107030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during cleaning, it was noted that the bur was broken inside the attachment.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
The reported product involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The device was sent to the product engineering group who concluded that due to markings on the shank surface of the bur as a result of debris within the attachment this would have resulted in increased rotational resistance and stress along the bur shank; this caused the bur to break.The debris within the attachment may have occurred due to insufficient bearing support or non-recommended cleaning procedures; however, this was not confirmed following evaluation of the returned attachment.
Event or Problem Description
It was reported that during cleaning, it was noted that the bur was broken inside the attachment.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

• Brand Name: 3.0MM MTCH HD, 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7951371
• Report Number: 0001811755-2018-01730
• Device Sequence Number: 1381305
• Product Code: HBE
• UDI-Device Identifier: 07613327097009
• UDI-Public: 07613327097009
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: 8450107030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5407120950C SN, (B)(4); 5407120950C SN, (B)(4)