MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO, D2.0MM X 105MM, SCALED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	705134
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported by the customer that "a medical device incident (mdi) with harm has been reported.Stryker variax 2.0 drill bit broke off in patient.".
Additional Manufacturer Narrative
The reported event could be confirmed as device was returned and matches the alleged event the received drill was visually inspected, and we can see that the fragment was broken and not returned for investigation purposes.The microscopic view of the breakage surface indicates brittle breakage caused by the application of high torsional and axial loads.The drill's cutting flutes also have nick marks, which indicate the device's usage.Furthermore, a hardness test according to (b)(4) on the returned item indicates the material being in accordance to the values in the material specification.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.Based on the investigation the root cause was attributed to user related, breakage was caused by application of combination of high load, torsional and axial in nature.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the customer that "a medical device incident (mdi) with harm has been reported.Stryker variax 2.0 drill bit broke off in patient.".

• Brand Name: DRILL, AO, D2.0MM X 105MM, SCALED
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20487176
• Report Number: 0008031020-2024-00604
• Device Sequence Number: 14356365
• Product Code: HWE
• UDI-Device Identifier: 07613327398922
• UDI-Public: (01)07613327398922(10)1000567258
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 705134
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown