MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM; PLATE, FIXATION, BONE

Model Number	705025
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
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
During axsos surgery, the drill bit contacted to an implant when drilling and was broken.The broken piece of the drill bit was completely removed from the patient.
Additional Manufacturer Narrative
The reported event that drill bit axsos 3 ti non-locking, short, ø2.5 x 216mm was alleged of issue s-11 (breakage during surgery) could be confirmed, since the device returned for evaluation and matches with the alleged failure mode.The device inspection revealed that returned drill bit is indeed completely broken off.The cutting edges of the drill bit is not very sharp and is damaged at several locations.The tip as well as the point of breakage (a bit below the helix) are very badly deformed / damaged, which indicates possibly inadequate handling during use (such as too much mechanical force).The event description mentions that ¿the drill bit contacted to an implant when drilling and was broken¿.The root cause can be attributed to a user related issue.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 ¿only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.¿ always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.¿ the design of the instrument must not be modified in any way.¿ ensure that drilling and cutting tools are sharp.¿ before every operation, ensure that all devices to be used during the operation function correctly with each other.¿ in the course of the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
During axsos surgery, the drill bit contacted to an implant when drilling and was broken.The broken piece of the drill bit was completely removed from the patient.

• Brand Name: DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7452311
• Report Number: 0008031020-2018-00315
• Device Sequence Number: 19175701
• Product Code: HRS
• UDI-Device Identifier: 07613327083422
• UDI-Public: (01)07613327083422
• 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): 07/17/2018

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: 00759V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR