MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI LOCKING, SHORT, 3.1 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	705031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/28/2021
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
The customer reported that while using the axsos 3 tibial plate ancillary during osteosynthesis of left tibial plateau, the drill bit broke and was left in the patient's tibia.
Event or Problem Description
The customer reported that while using the axsos 3 tibial plate ancillary during osteosynthesis of left tibial plateau, the drill bit broke and was left in the patient's tibia.
Additional Manufacturer Narrative
D4 lot number has been corrected.The reported condition could be confirmed based on the condition of the received drill bit and based on the received x-rays.On the x-rays is the fragment of the drill bit close to an inserted screw visible.The device inspection revealed the following: the front part is broken off at the cross over from the cutting flutes to the shaft.The fracture face has the typical view of a brittle overload fracture, at the fracture initiation zone are deformations visible, which indicates a metallic contact.In general it the drill bit in a very used condition, the remaining cutting edges are blunt and the are strong stress marks at the shaft visible.Also the flat surface at the coupling adapter has clearly visible wear marks.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 indicates that a metallic contact, for example with an already inserted screw did lead to a mechanical overload and finally the breakage of the device.Wear and tear may also have played a certain role, as blunt drill bit in general require more torque during use.If any further information is provided, the investigation report will be updated.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, SHORT, 3.1 X 216MM
• 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: 11902400
• Report Number: 0008031020-2021-00248
• Device Sequence Number: 11674650
• Product Code: HWE
• UDI-Device Identifier: 07613327083316
• UDI-Public: 07613327083316
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 705031
• Device Catalogue Number: 705031
• Device Lot Number: 11997Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1