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	01/22/2025
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
It was reported that: "a screw from the anis iii range became deformed and eventually broke at the head during ablation on a 14-year-old patient, making ablation impossible." measures/actions taken to complete the procedure: break the screw flush with the cortex and leave the remaining part in place.
Additional Manufacturer Narrative
The reported event could be confirmed, since the screw is broken as described in the event description.The device inspection revealed the following: the head of the broken screw and a strongly deformed fragment of the broken screw were returned for evaluation.Together with the screw was also a broken and strongly deformed washer returned, the washer is listed in the received implant sheet but otherwise not mentioned in any of the provided information, there was no allegation against this device made.The inspection of the screw head has shown that the head is strongly bent in one direction at the crossover from the shaft to the head.Also the remaining shaft has slight deformations in different directions.There are stress marks at the upper part of the shaft visible and there is an impression mark at one side of the screw head visible (red arrow), these marks were most likely caused by a strong contact with the washer.The microscopic investigation of the fracture face has shown that the fracture has the typical view of a ductile overload fracture, where the applied force is causing first a permanent distortion, visible at the twisted appearance on one side of the fracture, with subsequent fracture.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.Based on the provided information the root cause of the reported event cannot be defined.The evaluation has shown that there was an excessive contact between the washer and the screw, which could indicate that in situ load application did already lead to a deformation and weakening of the screw head and the washer.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that : "a screw from the asnis iii range became deformed and eventually broke at the head during ablation on a 14-year-old patient, making ablation impossible." measures/actions taken to complete the procedure: break the screw flush with the cortex and leave the remaining part in place.
Event or Problem Description
It was reported that : "a screw from the asnis iii range became deformed and eventually broke at the head during ablation on a 14-year-old patient, making ablation impossible." measures/actions taken to complete the procedure: break the screw flush with the cortex and leave the remaining part in place.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on the provided implant sheet the catalog- and lot number of the screw could be verified, but there is no further evaluation based on that possible.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 Ø4.0X40MM 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21404011
• Report Number: 0008031020-2025-00305
• Device Sequence Number: 12892718
• Product Code: HWC
• UDI-Device Identifier: 04546540089762
• UDI-Public: (01)04546540089762(17)330731(10)AC4588
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213199
• 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,Followup
• Report Date (Section B): 09/10/2025

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: AC4588
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 08/13/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/06/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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