MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT ACETABULAR PLATE MATTA 7 HOLES / L82.5MM FOR SCREWS Ø3.5/4.5MM; PLATE, FIXATION, BONE

Catalog Number	425757
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	12/19/2024
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: "patient had a pelvis fx, we used a 7 hole annealed plate to fix the fracture on (b)(6) 2024.No more than 3 weeks later the plate had broken and we had to do a revision/ removal of the stryker product and replace it with another company's product.Prolonged healing incurred".
Event or Problem Description
It was reported: "patient had a pelvis fx, we used a 7 hole annealed plate to fix the fracture on (b)(6) 2024.No more than 3 weeks later the plate had broken and we had to do a revision/ removal of the stryker product and replace it with another company's product.Prolonged healing incurred".
Additional Manufacturer Narrative
Correction: please refer to d4 lot number.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The acetabular plate was found to be broken from one of the 7 holes present.Typically, plates are weaker around the hole periphery due to less material.The nature of breakage indicates towards a progressive fracture most likely a fatigue one, evident by slight plastic deformation along the edges and over the breakage surfaces (shiny appearance), which normally happens when one segment separates gradually (fatigue manner) and rubs over the other surface.This plate is typically straight along the lines of holes; however, the plate was apparently found to curved with respect to the straight axis, indicating towards possible contouring of the plate prior to surgery.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, reason for which could be multifactorial like potential non-union or inadequate implant size selection & placement.However, without clinical reports and other patient information, the root cause of the issue could not be determined.Although bending, curving and twisting of these plates are allowed but the operative technique cautions the user that: extensive repeated bending of non-annealed matta plates can lead to loss of strength.If any additional information is provided, the investigation will be reassessed.

• Brand Name: STRAIGHT ACETABULAR PLATE MATTA 7 HOLES / L82.5MM FOR SCREWS Ø3.5/4.5MM
• 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: 22202598
• Report Number: 0008031020-2025-00964
• Device Sequence Number: 7667883
• Product Code: HRS
• UDI-Device Identifier: 04546540413598
• UDI-Public: (01)04546540413598(10)AL0463
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K223772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 425757
• Device Lot Number: AL0463
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: 62 YR
• Patient Sex: Female