MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER, SELF-HOLDING, LONG 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060233
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A broken screwdriver was reported, per received picture the blade / self-holding feature at the tip of the screwdriver is completely broken off.Patient, end user or surgery impact is unknown.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
A broken screwdriver was reported, per received picture the blade / self-holding feature at the tip of the screwdriver is completely broken off.Patient, end user or surgery impact is unknown.
Additional Manufacturer Narrative
The reported event could be confirmed, since evaluation revealed a broken blade.Inspection of the relevant dimensions was not possible due to the extent of damage.The breakage surface shows the typically structure of a brittle fracture, due to a bending overload.To prevent bending the screwdriver [sleeve] is laser-marked with the printing ¿do not lever¿.A process change was performed which triggered removal of the wch to prevent breakages of the moveable blade.The screwdriver manufacturing date of current case post-dates the process change.However, a design change does not prevent from application error during usage.Furthermore, it is recommended that the screwdriver shall be treated with an appropriate instrument spray after every usage.Nothing was reported during last pre-functional check and after last usage and since to information received, it was noticed during reprocessing steps made and thus, the case is rather linked to improper handling during reprocessing.Finally, it could not be excluded that the device was also pre-damaged in former surgeries.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.

• Brand Name: SCREWDRIVER, SELF-HOLDING, LONG 3.5 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: 20762112
• Report Number: 0009610622-2024-00922
• Device Sequence Number: 18248306
• Product Code: LXH
• UDI-Device Identifier: 04546540520425
• UDI-Public: 04546540520425
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 18060233
• Device Lot Number: KMW352101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2022
• 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