MAUDE Adverse Event Report: STRYKER GMBH ASNIS III CANNULATED SCREW, PARTIALLY THREADED D4.0X36MM TL12MM; SCREW, FIXATION, BONE

Catalog Number	604636S
Medical Device Problem Code	Difficult to Remove (1528)
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 not be confirmed since the device was not returned for evaluation and no other evidences in relation to the screw were provided.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation 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 CANNULATED SCREW, PARTIALLY THREADED D4.0X36MM TL12MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 24115663
• Report Number: 0008031020-2026-00042
• Device Sequence Number: 5941217
• Product Code: HWC
• UDI-Device Identifier: 04546540089724
• UDI-Public: (01)04546540089724(17)330731(10)AC6798
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K220319
• 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: 604636S
• Device Lot Number: AC6798
• Was Device Available for Evaluation?: No
• 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): No
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown