MAUDE Adverse Event Report: STRYKER GMBH EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702496
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "extraction of an asnis 4mm screw was difficult because the screw was bent in the bone.The extractor was used to remove the screw, but the tip of the extractor broke off.All fragments were removed.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the returned device inspection.The device inspection revealed the following: the reported bent screw was not returned.The visual inspection confirmed the tip of the extractor is broken off.The broken fragment was not returned.Overall, the extractor shows normal signs of use.The fracture surface is oblique, suggesting that significant lateral forces were involved at the time of breakage.The fracture surface displays signs of a typical brittle overload: no signs of plastic deformation, a shear lip on one side and a relatively rough and granular appearance.Altogether, this indicates the breakage was likely caused by excessive torque or sudden overload.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to 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 being user related.The breakage shows typical signs of an overload fracture caused by high torsional and lateral loads.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "extraction of an asnis 4mm screw was difficult because the screw was bent in the bone.The extractor was used to remove the screw, but the tip of the extractor broke off.All fragments were removed.".

• Brand Name: EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING
• 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: 23222590
• Report Number: 0008031020-2025-01674
• Device Sequence Number: 9509964
• Product Code: LXH
• UDI-Device Identifier: 04546540112415
• UDI-Public: (01)04546540112415(10)02695V
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 702496
• Device Lot Number: 02695V
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2016
• 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 Age: 18 YR
• Patient Sex: Male