MAUDE Adverse Event Report: STRYKER GMBH WASHER ASNIS III FOR SCREWS: Ø2.7/3.5/4.0MM; PLATE, FIXATION, BONE

Catalog Number	619905S
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
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.3/10/2025 - additional information received from the customer: "during the removal procedure, i easily found the end of the screw, with the help of a guide pin, but i tried to remove it for 45 min (tourniquet time 69 min instead of the planned 20-30 min), with a sharp broken end of the screw when it broke off, potentially irritating the overlying tendons." 7/23/2025: upon deep inspection of the returned screw, it has been noticed that a washer was also returned.The washer is also broken.
Additional Manufacturer Narrative
There was no allegation against the returned washer reported, nevertheless is this complaint rated as confirmed as a significant damage could be observed at the received device.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 washer is broken apart and strongly deformed, also are there excessive marks from a tool visible close to the breakage.The fracture face was inspected under the microscope, the top and the bottom are very shiny, which could be together with the before described damages an indication that the washer was cut apart during removal.Nevertheless it can also not be excluded that, the washer did bread or crack in situ as there are also signs of a fatigue fracture visible.Finally the root cause of this damage cannot be defined due to missing information.Fact is 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.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.

• Brand Name: WASHER ASNIS III FOR SCREWS: Ø2.7/3.5/4.0MM
• Common Device Name: PLATE, 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: 22835358
• Report Number: 0008031020-2025-01391
• Device Sequence Number: 13221125
• Product Code: HRS
• UDI-Device Identifier: 04546540430335
• UDI-Public: (01)04546540430335(17)340228(10)AG2800
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101056
• 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
• Report Date (Section B): 08/18/2025

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: 619905S
• Device Lot Number: AG2800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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 Age: 14 YR
• Patient Sex: Unknown