MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, SHORT T2 Ø5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060210
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "intermediate sleeve code 1806-0210 was slightly bent and did not allow the drill to pass through.It also could not be screwed into the next sleeve code 1806-0180".
Additional Manufacturer Narrative
The reported event could be confirmed, since physical evaluation revealed impaired assembling.The returned drill sleeve, short t2 ø5 mm in question was tested with along returned tissue protection sleeve, short t2 ø9 mm and trocar, short t2.Therefore, the drill sleeve was assembled within the tissue protection sleeve, and it was possible but with force.Furthermore, the trocar was also insertable within the drill sleeve, but it could only be assembled with increased force.Finally, the used and returned counterparts [tissue protection sleeve and trocar] were tested with an intact sample drill sleeve, short t2 ø5 mm and all working as intended.As the drill sleeve, short t2 ø5 mm had been in use for a longer time [manufactured in 2020] we pre-suppose that the device had fulfilled its tasks in former surgeries as intended and has to be replaced as stated in instructions for cleaning, sterilization, inspection and maintenance.Based on above and since the device was already manufactured in 2020 the case is rather related to inadequate handling [e.G.Dropped down] during last usage or at time of reprocessing; in case of intended use such damage would not have occurred.We exclude a manufacturing issue since any deviation in device geometry would have been already noticed in the beginning.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "intermediate sleeve code 1806-0210 was slightly bent and did not allow the drill to pass through.It also could not be screwed into the next sleeve code 1806-0180".

• Brand Name: DRILL SLEEVE, SHORT T2 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20869124
• Report Number: 0009610622-2024-00945
• Device Sequence Number: 8694105
• Product Code: LXH
• UDI-Device Identifier: 04546540196163
• UDI-Public: (01)04546540196163(11)200106(10)K0C9BDD
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 18060210
• Device Lot Number: K0C9BDD
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• 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