MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X44MM TL15MM; SCREW, FIXATION, BONE

Catalog Number	325044
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during a surgery to repair a fractured patella the surgeon used asnis 4.0 cannulated screws.After inserting three 1.4 threaded k-wires he drilled over them with the 2.7 cannulated drill bit.He then inserted the first two screws over the wires until desired compression was achieved.During insertion of the third screw the surgeon felt unusual resistance and decided to take an x-ray.The picture revealed a metal fragment in the patella separate from the screws and wires.After deliberation, the surgeon took the last screw out and it appeared as though the thread on the end of the screw had broken off in the bone.He removed as much of the fragment as possible and proceeded to finish placing another screw.He moved on to cerclage the patella and finish the surgery".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to d9 product not returned for investigation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during a surgery to repair a fractured patella the surgeon used asnis 4.0 cannulated screws.After inserting three 1.4 threaded k-wires he drilled over them with the 2.7 cannulated drill bit.He then inserted the first two screws over the wires until desired compression was achieved.During insertion of the third screw the surgeon felt unusual resistance and decided to take an x-ray.The picture revealed a metal fragment in the patella separate from the screws and wires.After deliberation, the surgeon took the last screw out and it appeared as though the thread on the end of the screw had broken off in the bone.He removed as much of the fragment as possible and proceeded to finish placing another screw.He moved on to cerclage the patella and finish the surgery".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X44MM TL15MM
• 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: 22835236
• Report Number: 0008031020-2025-01386
• Device Sequence Number: 8677034
• Product Code: HWC
• UDI-Device Identifier: 07613327078008
• UDI-Public: 07613327078008
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 325044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 54 YR
• Patient Sex: Female