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

Model Number	705025S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/08/2020
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 was reported, after axsos df surgery, it was found that the tip of the drill bit was remained to the patient by x-rays.The surgeon did not notice the drill breakage during the surgery.
Event or Problem Description
It was reported, after axsos df surgery, it was found that the tip of the drill bit was remained to the patient by x-rays.The surgeon did not notice the drill breakage during the surgery.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the tip of the returned drill bit is indeed completely broken / snapped off.The shaft is bent and spiral scratches as well as metal abrasions / discolorations are visible.The mentioned discoloration was caused by heat transfer due to metal contact (drill sleeve).The damages / spiral scratches of the drill shaft clearly indicate that the drill shaft was in contact with the drill sleeve (metal abrasion).As mentioned the shaft is bent which indicates as well that far too much mechanical force had been applied.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 failure was caused due to inadequate angulation during drilling, as the drill shaft came in contact with the drill sleeve which resulted in the tip breakage (powerful dynamically overload during use).If any further information is provided, the investigation report will be updated.

• Brand Name: DRILL BIT AXSOS 3 TI 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 ; CH 2545
• MDR Report Key: 9667673
• Report Number: 0008031020-2020-00267
• Device Sequence Number: 2678522
• Product Code: HWE
• UDI-Device Identifier: 07613327083439
• UDI-Public: 07613327083439
• 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): 03/16/2020

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: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: 705025S
• Device Catalogue Number: 705025S
• Device Lot Number: 12750D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1