MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE MTP, LEFT ANCHORAGE; PLATE, FIXATION, BONE

Catalog Number	PLP14341
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/12/2025
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 the mtp plate was broken after implantation in the patient.The primary surgery in question was the arthrodesis for hallux valgus and rigidus.The surgeon has performed the revision operation on the broken plate.
Additional Manufacturer Narrative
Corrected fields: product long description (d1), lot no.(d4), catalog no.(d4), gtin (d4), and clinical signs code grid (h6).The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received anchorage plate was found to be broken from the cross-plate hole region, typically where the fracture line is.The nature of breakage exhibits a typical fatigue failure evident by plastic deformation along the edges and some of the breakage surfaces, which normally happens when one segment separates gradually (fatigue manner) and rubs over the other surface.A secondary fracture line can also be seen in one of the segments, all of which together confirms a fatigue fracture.The fracture appears to have been caused due to overloading over a long period.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, it can be said that the plate broke in fatigue manner possibly due to overloading, however without clinical reports and other patient information, the root cause of the issue could not be determined.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the mtp plate was broken after implantation in the patient.The primary surgery in question was the arthrodesis for hallux valgus and rigidus.The surgeon has performed the revision operation on the broken plate.

• Brand Name: CROSS PLATE MTP, LEFT ANCHORAGE
• 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: 21806635
• Report Number: 0008031020-2025-00675
• Device Sequence Number: 8974362
• Product Code: HRS
• UDI-Device Identifier: 07613252260554
• UDI-Public: (01)07613252260554(10)AL6225
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: Lay User/Patient
• Device Catalogue Number: PLP14341
• Device Lot Number: AL6225
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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 Sex: Unknown