MAUDE Adverse Event Report: STRYKER GMBH CALIBRATED DRILL BIT 3.1MM X 285MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	703585
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that the drill bit broke during the procedure; the broken-off piece remains in the patient.
Event or Problem Description
It was reported that the drill bit broke during the procedure; the broken-off piece remains in the patient.
Additional Manufacturer Narrative
D4 lot number corrected.The reported condition could be confirmed as the drill bit is broken as complained.The device inspection revealed the following: the visual inspection has shown that the tip of the drill bit with is broken off at the crossover from the cutting edges to the shaft.The fracture has the typical view of an brittle overload fracture, the fracture initiation zone including chevron marks can be identified.In general is the drill bit in a used condition with wear marks all over.A hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to be user related.The appearance of the fracture zone a mechanical overload, most likely by an excessive metallic contact, did lead to the breakage of the drill bit.If any further information is provided, the investigation report will be updated.

• Brand Name: CALIBRATED DRILL BIT 3.1MM X 285MM, AO
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12050055
• Report Number: 0008031020-2021-00268
• Device Sequence Number: 14364376
• Product Code: HWE
• UDI-Device Identifier: 04546540694072
• UDI-Public: 04546540694072
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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 Model Number: 703585
• Device Catalogue Number: 703585
• Device Lot Number: K0DCC1B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1