MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V2 - LEFT; PLATE, FIXATION, BONE

Model Number	AE4175
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/20/2025
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: "mtp anchorage 1 plate broke within 2 weeks of being implanted.There's "persistent pain from patient, confirmed by xray.Xray confirmed 2 weeks post op that the plate had broke, revision surgery 2.5 months from primary surgery.".
Event or Problem Description
It was reported that: "mtp anchorage 1 plate broke within 2 weeks of being implanted.There's "persistent pain from patient, confirmed by xray.Xray confirmed 2 weeks post op that the plate had broke, revision surgery 2.5 months from primary surgery.".
Additional Manufacturer Narrative
Correction to h3(device evaluated by mfg).The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received anchorage plate was found broken from one of the proximal holes.There are some damage marks in the fractured hole which were caused by the rubbing from other plate fragment, after the breakage.Also, in the other fragment, the corresponding damage on the bottom side are visible.A significant amount of the plastic deformation observed along the broken edges of the plate which normally happens when one segment separates gradually (fatigue manner) and rubs over the other surface.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 plate was broken in a fatigue manner, however without clinical reports and other patient information, an exact root cause of the issue could not be determined.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PLATE ANCHORAGE MTP / VERSION V2 - LEFT
• 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: 22242348
• Report Number: 0008031020-2025-00971
• Device Sequence Number: 21099412
• Product Code: HRS
• UDI-Device Identifier: 07613252260493
• UDI-Public: (01)07613252260493(17)281031(10)AE4175
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: AE4175
• Device Catalogue Number: PLP11341
• Device Lot Number: AE4175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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