MAUDE Adverse Event Report: STRYKER GMBH ASNIS III EXTRACTOR FOR SCREWS:D4.0MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702496
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the extraction of asnis 4.0, the extraction proved difficult due to the bone quality being favourable.Upon using the extractor, the tip of the extractor broke off.The asinis 4.0 could not be removed and remains implanted in the body.It is noted that fragments remain within the body.The physician believes these fragments can be removed during the attempted re-extraction of the asnis.
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 is broken as described in the event description.The device inspection revealed the following: the extractor was returned and the breakage can be confirmed.The fragment was not returned for evaluation as it did remain in the screw head.In general the device in a good condition, just slight wear marks could be observed.The fracture face is oblique, which is an indication for high lateral forces when the breakage occurred.The microscopic inspection of the fracture face did show the for a brittle overload fracture typical view, with no signs of plastic deformation before the breakage and a shear lip on one side.The shear lip is also a sign for high lateral load when the device broke.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 labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No corrective actions are required at this time.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
It was reported that during the extraction of asnis 4.0, the extraction proved difficult due to the bone quality being favourable.Upon using the extractor, the tip of the extractor broke off.The asinis 4.0 could not be removed and remains implanted in the body.It is noted that fragments remain within the body.The physician believes these fragments can be removed during the attempted re-extraction of the asnis.

• Brand Name: ASNIS III EXTRACTOR FOR SCREWS:D4.0MM 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: 24116056
• Report Number: 0008031020-2026-00043
• Device Sequence Number: 9515621
• Product Code: LXH
• UDI-Device Identifier: 04546540112415
• UDI-Public: (01)04546540112415(10)17247D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 17247D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2020
• 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 Sex: Unknown