MAUDE Adverse Event Report: STRYKER GMBH CROWN DRILL T2 Ø10X195 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18062020
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during a t2 humerus surgery, a crown drill struck a k-wire temporarily fixed to the humeral head and broke part of the crown drill.The fragment was immediately removed from the patient.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during a t2 humerus surgery, a crown drill struck a k-wire temporarily fixed to the humeral head and broke part of the crown drill.The fragment was immediately removed from the patient.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned drill was confirmed based on the catalog # and the lot # marked.It could be confirmed that one tooth broke off.The reported fragment was not returned.The surface of the breakage gives indication of a sudden brittle fracture.The other teeth show signs of wear and slight deformation at the tip.The damage gives indication that the instrument indeed struck a k-wire, as reported.Dimensional inspection has shown the device to be within specification.Based on investigation, the root cause was attributed to a user related issue.The breakage occurred as a direct result of the instrument drilling against a k-wire.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 more information is provided, the case will be reassessed.

• Brand Name: CROWN DRILL T2 Ø10X195 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19187813
• Report Number: 0009610622-2024-00170
• Device Sequence Number: 15262015
• Product Code: LXH
• UDI-Device Identifier: 04546540412065
• UDI-Public: 04546540412065
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/06/2024

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: 18062020
• Device Lot Number: K03F74E
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2019
• 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
• Patient Age: 71 YR
• Patient Sex: Female