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 705031

Device Problem Break (1069)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The drill was reported to be broken.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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, based on past complaints and risk management file some of the possible causes are but not limited to: too high torque, drill getting in contact with the implant (hard/metal object) due to misalignment, mistreatment of the instrument etc.If any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

Event Description

The drill was reported to be broken.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, SHORT, 3.1 X 216MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10505083
• MDR Text Key: 207315606
• Report Number: 0008031020-2020-02217
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327083316
• UDI-Public: 07613327083316
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

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
• Device Operator: Health Professional
• Device Model Number: 705031
• Device Catalogue Number: 705031
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1