MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 NON-LOCKING, SHORT, Ø2.5 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	705025S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It is reported a drill bit has "broken".Additional information received: the surgery was completed successfully by opening a new drill.There was a slight delay in the surgery as a consequence.
Additional Manufacturer Narrative
Please note the corrections to h5 and h8 as the device is a sterile drill bit.Please also note the correction to h6 clinical signs code.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received drill bit shows signs of extensive usage ad evident by spiral scratches of the drill shaft.The breakage from the tip is a brittle fracture as indicated by the presence of shiny surface.The breakage is caused due to an application of excessive torsional & longitudinal force.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.Based on investigation, the root cause was attributed to a user related issue.The breakage was caused by an application of excessive torsional & longitudinal force.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It is reported a drill bit has "broken".Additional information received: the surgery was completed successfully by opening a new drill.There was a slight delay in the surgery as a consequence.

• Brand Name: DRILL BIT AXSOS 3 NON-LOCKING, SHORT, Ø2.5 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
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15255092
• Report Number: 0008031020-2022-00396
• Device Sequence Number: 17579093
• Product Code: HWE
• UDI-Device Identifier: 07613327083439
• UDI-Public: 07613327083439
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/02/2022

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: 11/30/2023
• Device Model Number: 705025S
• Device Catalogue Number: 705025S
• Device Lot Number: 15083Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown