MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, 2.5 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	705025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and also could not be confirmed on the basis of the provided x-ray.The device inspection was not possible as the product was not returned for investigation.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿ensure that you are familiar with the intended uses, compatibility and correct handling of the instrument, which are described in the operative technique of the product system.Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.The stryker "instructions for cleaning, sterilization, inspection and maintenance" (literature number l24002000) help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ formal medical opinion was sought from an experienced independent medical expert as below; ¿actually, we cannot confirm from x-ray that the drill bit tip is embedded in the bone since we only have one direction.To be sure we should have two directions.Most likely it does not cause any patient impact since it is medical grade steel.No we can¿t confirm the bone quality from the x-ray, especially since there is some additional cast/ bandage on the bone which clouds the bone and on top of that there is an additional shadow on the bone where the drill bit is.Hard bone maybe a reason, maybe the drill bit was no longer sharp, maybe too much force was used, maybe the direction as a bit off? there are many additional factors that could have caused the breakage, it may also have been a combination of factors.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, some of the probable causes of breakage could be hard bone of patient or blunt drill bit or user error such as application of too much force or misdrilling or a combination of these factors.If device is returned or any further information is provided, the investigation report will be reassessed.Device is not available; disposed of by hospital.
Event or Problem Description
It was reported: "that the tip of 2.5 drill bit broke off while drilling for a 3.5 screw.The surgeon did not attempt to remove as the tip was embedded in the bone.No patient impact to my knowledge".
Additional Manufacturer Narrative
Please note the lot number of the device.
Event or Problem Description
It was reported: "that the tip of 2.5 drill bit broke off while drilling for a 3.5 screw.The surgeon did not attempt to remove as the tip was embedded in the bone.No patient impact to my knowledge".

• Brand Name: DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, 2.5 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
• MDR Report Key: 11499243
• Report Number: 0008031020-2021-00090
• Device Sequence Number: 2776902
• Product Code: HWE
• UDI-Device Identifier: 07613327083422
• UDI-Public: 07613327083422
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 03/30/2021

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: 705025
• Device Catalogue Number: 705025
• Device Lot Number: 12742D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR