MAUDE Adverse Event Report: STRYKER GMBH NON LOCKING SCREW ANCHORAGE Ø3.0MM/L22MM; PLATE, FIXATION, BONE

Catalog Number	PLSS3022
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
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, when surgeon was installing an anchorage ancillary plate, the head of the unlocked screw broke during screwing, even though there were no particular stresses.As a result, the screw could not be removed and had to remain in place.No clinical signs were observed.Screw was impossible to remove.No complications for the patient if the material is left in place.However, if the patient is bothered by the screw, it may have to be removed, with the attendant risks.On the other hand, the surgeon found it distressing that a screw fractured when he tried to tighten it (locked screw) and that it was impossible to remove it.Fortunately, it had been well placed all along and the plate didn't have to be replaced.
Event or Problem Description
It was reported that, when surgeon was installing an anchorage ancillary plate, the head of the unlocked screw broke during screwing, even though there were no particular stresses.As a result, the screw could not be removed and had to remain in place.No clinical signs were observed.Screw was impossible to remove.No complications for the patient if the material is left in place.However, if the patient is bothered by the screw, it may have to be removed, with the attendant risks.On the other hand, the surgeon found it distressing that a screw fractured when he tried to tighten it (locked screw) and that it was impossible to remove it.Fortunately, it had been well placed all along and the plate didn't have to be replaced.
Additional Manufacturer Narrative
The reported event could be confirmed since the broken head of the screw was returned for evaluation.The complete alleged screw was not returned for evaluation, only the head was returned.The drive section of the screw head showed significant deformation in a few pegs (top surface & inside), indicating towards application of high torsional load.The underside of the head with the fracture surface shows a typical ductile failure due to a continuous high load application.The batch record could not be reviewed since the lot number was not communicated or could be retrieved.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on the available information, the cause of the failure is most likely user related as evident by signs of high load application in the returned head.The operative technique cautions the user that applying excessive torque during screw insertion is not recommended, and may result in damage to the screw head.In particular for nonlocking screws it is recommended to tighten the screw head until contact with the plate, then release from tightening.If any additional information is provided, the investigation will be reassessed.

• Brand Name: NON LOCKING SCREW ANCHORAGE Ø3.0MM/L22MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22632481
• Report Number: 0008031020-2025-01307
• Device Sequence Number: 9003034
• Product Code: HRS
• UDI-Device Identifier: 07613252262718
• UDI-Public: 07613252262718
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: Lay User/Patient
• Device Catalogue Number: PLSS3022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown