MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X40MM TL13.5MM; SCREW, FIXATION, BONE

Catalog Number	604640S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
Primary surgery was performed on (b)(6) 2023.Bone fusion was achieved and revision surgery for explantation was performed on (b)(6) 2025.The head of asnis screw was deformed when removing the screw.Surgeon used the extractor to remove the deformed screw, however, the tip of the extractor was broken.Surgeon tried to remove the screw with using pliers, however, the head of screw was broken and the screw could not be removed.
Additional Manufacturer Narrative
Correction - please refer b2 outcomes attributed to ae, d9 - product not returned, g1 reporting contact.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences 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
Primary surgery was performed on (b)(6) 2023.Bone fusion was achieved and revision surgery for explantation was performed on (b)(6) 2025.The head of asnis screw was deformed when removing the screw.Surgeon used the extractor to remove the deformed screw, however, the tip of the extractor was broken.Surgeon tried to remove the screw with using pliers, however, the head of screw was broken and the screw could not be removed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X40MM TL13.5MM
• 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: 21395639
• Report Number: 0008031020-2025-00299
• Device Sequence Number: 8471510
• Product Code: HWC
• UDI-Device Identifier: 04546540089762
• UDI-Public: (01)04546540089762(17)270331(10)K33408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 604640S
• Device Lot Number: K33408
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2022
• 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; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male