MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM; PLATE, FIXATION, BONE

Catalog Number	705031
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.Broken piece remained inside the patient.
Event or Problem Description
During axsos surgery, the drill bit broke inside the patient's bone when drilling of a distal 9th hole of a plate.The broken drill is planned to be removed with the implant removal surgery.
Additional Manufacturer Narrative
The reported event that drill bit axsos 3 ti locking, short, ø3.1 x 216mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by an overtorque application on the device.Indeed, the device inspection revealed the following: the device broke in a such a way that only 4 mm of the helical part of the drill is still remaining.On the length of the drill, some usage marks can be noticed, such as circular marks probably due to the use of a drill guide.The breakage surface shows some bright circular breakage lines, which prove that an over-torque phenomenon was involved in this event.A test was performed in order to check the hardness of the device, to confirm that it complies with the requirement of stryker.Three measures were performed in the flat surface of the drill bit, where the ao connection is.The first measured value of hardness was: 43.5 hrc, the second value 43.6 hrc and the last measure 40.1 hrc.This gives a mean value of 42 hrc to the device.The minimum requirement according to the drawing is 40 hrc.The hardness of the device is thus within specifications.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
During axsos surgery, the drill bit broke inside the patient's bone when drilling of a distal 9th hole of a plate.The broken drill is planned to be removed with the implant removal surgery.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7593474
• Report Number: 0008031020-2018-00456
• Device Sequence Number: 13763683
• Product Code: HRS
• UDI-Device Identifier: 07613327083316
• UDI-Public: 07613327083316
• Combination Product (Y/N): N
• PMA/510(K) Number: K141121
• 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): 07/31/2018

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 Catalogue Number: 705031
• Device Lot Number: 07285L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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: 30 YR
• Patient Weight: 70