MAUDE Adverse Event Report: STRYKER GMBH CROWN DRILL IMPLANT EXTRACTION SET Ø5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066167
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the extraction of 4.0ccs was difficult, the screw head was removed and a conical extractor small was used, but the tip broke off and remained in the screw.The inside of the crown drill was clogged.Finally, all extraction was completed".
Event or Problem Description
As reported: "the extraction of 4.0ccs was difficult, the screw head was removed and a conical extractor small was used, but the tip broke off and remained in the screw.The inside of the crown drill was clogged.Finally, all extraction was completed".
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event could be confirmed, since the device was returned clogged as reported.The device inspection revealed the following: the crown drill is clogged with foreign material inside its cannulation (most likely material generated during surgery such as bone debris).The clogged material could be easily removed by pushing it slightly with a pin.The cannulation was then free from any foreign material.Based on investigation, the root cause was attributed to a user related issue.The event was caused by the user not ensuring cleanliness of the cannulated instrument during the procedure, therefore inducing debris clogging.As a reminder, the instructions for use state the following: « users have to ensure the cleanliness of the cannulation of the instrument pre-, inter- and post operatively to make sure that bone debris does not accumulate ».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 IMPLANT EXTRACTION SET Ø5 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21368805
• Report Number: 0008031020-2025-00278
• Device Sequence Number: 8438108
• Product Code: LXH
• UDI-Device Identifier: 04546540510037
• UDI-Public: 04546540510037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/21/2025

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: 18066167
• Device Lot Number: K0823CB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2017
• 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: 18 YR
• Patient Sex: Male