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	705031S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
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
As reported: "drilling is performed using a drill sleeve short.After drilling, the drill did not come out of the sleeve.Doctor's opinion: it is possible that the inside of the sleeve was drilled and scraped for some reason.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The device inspection revealed the following: the received drill showed severe scuff marks around the region from where the flutes begin and extended partially upto the starting of the flutes.The nature of the scuff marks suggests interaction of the drill with the drill sleeve wall and metal debris (caused due to interaction of the drill with the sleeve) or bone residue inside the cannulation, potentially.The received drill could not be passed completely through the received drill sleeve as the drill sleeve was slightly clogged and roughed up internally.A resistance could be felt while inserting the drill through the sleeve.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause of the jamming is user related.The visual evidence indicates towards a potential clogging and damage of the cannulation by metal debris (fretting) generated during the surgery, involving some misalignment as well.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "drilling is performed using a drill sleeve short.After drilling, the drill did not come out of the sleeve.Doctor's opinion: it is possible that the inside of the sleeve was drilled and scraped for some reason.".

• 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: 11051686
• Report Number: 0008031020-2020-02588
• Device Sequence Number: 11822541
• Product Code: HWE
• UDI-Device Identifier: 07613327083330
• UDI-Public: 07613327083330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/17/2021

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 Expiration Date: 11/30/2024
• Device Model Number: 705031S
• Device Catalogue Number: 705031S
• Device Lot Number: 16560D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1