MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	705031S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
During orif procedure, drill bit was used to make a distal hole.Then when a screw was attempted to insert, it could not be inserted normally, even though reinsertion of the screw was attempted for a few times.The nurse pointed out that it could be possible that the tip of the drill was broken (missing a part).The surgeon¿s opinion: the patient had thick cortex, this could be a reason that the screw could not be inserted well.
Additional Manufacturer Narrative
The reported event could not be confirmed.The device inspection revealed the following: only the shaft of the returned drill bit shows some wear but the drill bit as such is still intact.No tip breakage is visible.The device is conforming to specifications and is fully functional.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 other related.There was no failure with the returned drill bit.It was mentioned that there were some problems inserting a screw.If any further information is provided, the investigation report will be updated.
Event or Problem Description
During orif procedure, drill bit was used to make a distal hole.Then when a screw was attempted to insert, it could not be inserted normally, even though reinsertion of the screw was attempted for a few times.The nurse pointed out that it could be possible that the tip of the drill was broken (missing a part).The surgeon¿s opinion: the patient had thick cortex, this could be a reason that the screw could not be inserted well.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9521815
• Report Number: 0008031020-2019-02369
• Device Sequence Number: 14264152
• Product Code: HWE
• UDI-Device Identifier: 07613327083330
• UDI-Public: 07613327083330
• Combination Product (Y/N): N
• 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): 03/20/2020

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: 04/30/2024
• Device Model Number: 705031S
• Device Catalogue Number: 705031S
• Device Lot Number: 17177Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1