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

Catalog Number	18060233
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "discoloration of the surface.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The received screwdriver, self-holding, and long screwdriver were visually inspected in which device was found to be in good condition.But we see discoloration of the screwdriver blade, on different spots throughout the periphery of the shaft.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.The cleaning, sterilization, inspection and maintenance (l24002000) states: ¿the recommended concentrations and times for device immersion in the cleaning solutions and/ or disinfectants given by the detergent manufacturers shall be observed.If these concentrations and times are exceeded significantly, discoloration or corrosion could occur with some materials.This could also happen if rinsing after cleaning and/or disinfecting is insufficient.¿ [original statements]: no indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to being user related.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "discoloration of the surface".

• Brand Name: SCREWDRIVER, SELF-HOLDING, LONG SCREWDRIVER, SELF-HOLDING 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: 18908605
• Report Number: 0009610622-2024-00099
• Device Sequence Number: 18062865
• 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): 05/21/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/21/2024
• 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