MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X50MM TL17MM; SCREW, FIXATION, BONE

Catalog Number	604650S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
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
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 g4 510 k.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences, like x-rays, were provided for investigation of the screw.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.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X50MM TL17MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21621807
• Report Number: 0008031020-2025-00418
• Device Sequence Number: 6827893
• Product Code: HWC
• UDI-Device Identifier: 04546540089861
• UDI-Public: (01)04546540089861(17)261231(10)H64877
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 604650S
• Device Lot Number: H64877
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2022
• 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: Other
• Patient Age: 14 YR
• Patient Sex: Male