MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CROWN DRILL IMPLANT EXTRACTION SET Ø4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6166
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complained chipping of the crown drill can not be confirmed.The device inspection revealed the following: the visual inspection has shown that received device is in a good condition with no by the naked eye visible damages.A function test with a saw bone was made and it was detected that the device does not cut as expected.Therefore an evaluation of the crown drill cutting edges under the microscope was made.The evaluation has shown that the cutting edges are at the inside rounded, which leads to the decreased cutting performance.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 investigation, the root cause was attributed to a user related issue.The failure was caused by the in the event description mentioned metallic contact with the screw, which caused a mechanical overload and the observed deformation of the cutting edges.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during removal, the screw stopped in the middle and the tip of the extractor broke off when the surgeon kept turning it.The bone around the screw was then drilled using a crown drill and the screw was removed.In doing so, the drill tip may have hit the screw and chipped it.".
Event or Problem Description
As reported: "during removal, the screw stopped in the middle and the tip of the extractor broke off when the surgeon kept turning it.The bone around the screw was then drilled using a crown drill and the screw was removed.In doing so, the drill tip may have hit the screw and chipped it.".
Additional Manufacturer Narrative
The complained chipping of the crown drill can not be confirmed.The device inspection revealed the following: the visual inspection has shown that received device is in a good condition with no by the naked eye visible damages.A function test with a saw bone was made and it was detected that the device does not cut as expected.Therefore an evaluation of the crown drill cutting edges under the microscope was made.The evaluation has shown that the cutting edges are at the inside rounded, which leads to the decreased cutting performance.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 investigation, the root cause was attributed to a user related issue.The failure was caused by the in the event description mentioned metallic contact with the screw, which caused a mechanical overload and the observed deformation of the cutting edges.If more information is provided, the case will be reassessed.

• Brand Name: CROWN DRILL IMPLANT EXTRACTION SET Ø4 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13595953
• Report Number: 0009610622-2022-00068
• Device Sequence Number: 14917068
• Product Code: LXH
• UDI-Device Identifier: 04546540510020
• UDI-Public: 04546540510020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: 1806-6166
• Device Catalogue Number: 18066166
• Device Lot Number: K055602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2017
• 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 Sex: Unknown