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

Catalog Number	18060233
Medical Device Problem Codes	Crack (1135); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
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: "tip of the scream turner is clearly bent.Crack in the material after use.No patient has any trouble and the operation was ended successfully.".
Event or Problem Description
As reported: "tip of the scream turner is clearly bent.Crack in the material after use.No patient has any trouble and the operation was ended successfully.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: during visual inspection, severe rubbing marks were observed on the surface of the sleeve, most probably due to misalignment during usage inside the tissue protection sleeve or target device.The hexagonal tip of the screwdriver was found worn out under excess friction due to excess application of torsional force during usage, which is further confirmed by flattening of the hex corners and excess rubbing marks on the tip.Due to the misalignment of the sleeve and excess torsional force on the screwdriver, the shaft of the screwdriver got bent.The bending of the screwdriver resulted in the application of excess tensile force on the walls of the sleeve, and ultimately, the sleeve got cracked.To prevent bending of the screwdriver, the sleeve is laser-marked with the printing ¿do not lever.¿ furthermore, a hardness test according to rockwell on the returned item indicates the material is in accordance with the values in the material specification.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 the investigation, the root cause was attributed to a user-related issue.The event was caused by the misalignment of devices during usage, resulting in the application of excess torsional and bending forces.If more information is provided, the case will be reassessed.

• 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: 19563441
• Report Number: 0009610622-2024-00295
• Device Sequence Number: 7680844
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 18060233
• Device Lot Number: KMW352201
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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