MAUDE Adverse Event Report: STRYKER GMBH ELASTOSIL HANDLE SMALL SPS AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702428
Medical Device Problem Codes	Residue After Decontamination (2325); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During reprocessing at the sterilization department the staff observed changes in the surface of the affected items.
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 for evaluation and matches the alleged failure.The device inspection revealed the following: in the received device, severe deformation and damage is seen in the cannulated head of the screwdriver.A lot of damage / scratch marks are also visible proximal to the damaged portion.It looks like there are strong contacts of the cannulated head, most probably with a sharper object.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 event was caused by the repeated excess contact of the device with a sharper object, either during use or reprocessing.If more information is provided, the case will be reassessed.
Event or Problem Description
During reprocessing at the sterilization department the staff observed changes in the surface of the affected items.
Additional Manufacturer Narrative
Please note the correction to h6 device code.
Event or Problem Description
During reprocessing at the sterilization department the staff observed changes in the surface of the affected items.

• Brand Name: ELASTOSIL HANDLE SMALL SPS AO COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22327263
• Report Number: 0008031020-2025-01012
• Device Sequence Number: 15561011
• Product Code: LXH
• UDI-Device Identifier: 04546540112262
• UDI-Public: (01)04546540112262(10)2340AA
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 11/06/2025

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: 702428
• Device Lot Number: 2340AA
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 10/09/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/29/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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