MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.5MM RADIOLUCENT DRILL BIT; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	4200355035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during surgery, while t2 drilling the humerus for distal screw fixation the drill broke at the base.It was reported that the front cortical bone did not come off.It was also reported that there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
The reported event, for drill bit breakage, was not confirmed as the drill bit was not returned for evaluation.Without the drill bit, the root cause cannot be determined.
Event or Problem Description
It was reported that during surgery, while t2 drilling the humerus for distal screw fixation the drill broke at the base.It was reported that the front cortical bone did not come off.It was also reported that there were no adverse consequences and the procedure was completed successfully.

• Brand Name: 3.5MM RADIOLUCENT DRILL BIT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8348077
• Report Number: 0001811755-2019-00572
• Device Sequence Number: 1832747
• Product Code: HWE
• UDI-Device Identifier: 04546540217165
• UDI-Public: 04546540217165
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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 Expiration Date: 09/01/2023
• Device Catalogue Number: 4200355035
• Device Lot Number: 18253017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1