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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
When extracting the asnis screw that had been inserted into the distal end of the humerus, the screw was left in the patient's body in a damaged state and could not be removed and the extractor was broke off.The screw could not be removed and part of it remained.As a result, the screw remained in the patient.All the debris were removed from the surgical field/patient.
Additional Manufacturer Narrative
Correction - please refer h6 method code and clinical code.The reported event could be confirmed, since the device is broken as described in the event description.The device inspection revealed the following: the extractor was returned for evaluation and it can be confirmed that the tip is broken off, the fragment was not returned.The device, which was manufactured in the year 2019, is in a very used condition.The laser markings are barely readable.The lot number was initially not reported as is not possible to read it with the naked eyed anymore, the lot number could be identified under the microscope during the investigation.A microscopic inspection of the fracture face was performed.The absence of plastic deformation and the presence a smooth surface with a shear lip on one side indicates a sudden brittle fracture.The fracture face is oblique, indicating the device was exposed to high lateral forces when it broke.The findings indicate that a torsional and bending overload did lead to the breakage of the device.However, it cannot be excluded that residual stress from previous usage also contributed to the breakage.Furthermore, a hardness test according to (b)(6) on the returned item indicates the material being 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 being user related.The breakage shows typical signs of an overload fracture caused by high torsional and lateral loads.Wear and tear may also have played a certain role.If more information is provided, the case will be reassessed.
Event or Problem Description
When extracting the asnis screw that had been inserted into the distal end of the humerus, the screw was left in the patient's body in a damaged state and could not be removed and the extractor was broke off.The screw could not be removed and part of it remained.As a result, the screw remained in the patient.All the debris were removed from the surgical field/patient.

• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21595222
• Report Number: 0008031020-2025-00408
• Device Sequence Number: 12849480
• Product Code: LXH
• UDI-Device Identifier: 04546540112415
• UDI-Public: (01)04546540112415(10)16591D
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 702496
• Device Lot Number: 16591D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Male