MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW PANGEA PLATFORM 3.5MM / T15 / L60MM; SCREW, FIXATION, BONE

Catalog Number	541560
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a case where a patient experienced hardware failure after the initial operation.Plate hardware locking screws became prominent resulting in hwr surgery and eventually a total knee replacement on (b)(6) 2025".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a case where a patient experienced hardware failure after the initial operation.Plate hardware locking screws became prominent resulting in hwr surgery and eventually a total knee replacement on (b)(6) 2025".
Additional Manufacturer Narrative
The reported event was rated as confirmed due to the observed damages at the received plates.In total six locking screws were returned together with the distal medial femur plate.There was no information provided how many screw were affected by the reported screw prominence.The evaluation of the corresponding plate has shown that two of the universal holes were damaged in a manner that a proper locking of the screw was not possible anymore.Based on that it can be concluded that the two returned screws with the most severe damages at the locking head were affected by this occurrence.In addition are these the longest returned screws, which typical for the affected distal screw holes.The device inspection revealed the following: the inspection of the screws has shown that the locking threads are slightly damaged, especially the first thread flanks are flattened.This could be an indication for an excessive contact between the screw and the plate during the insertion, but it can also not be excluded that the damages occurred in-situ due to friction between the screw and the plate.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.The complaint was reviewed by r and d, including a interview with the operating physician.The review came to the result that the locking screws shown normal trace of use.No product related issue could be detected during the investigation.Based on the provided information, no pre-, intra- and post-operative x-rays in different planes, operation reports, detailed patient details, history and activity was provided, the root cause of the reported event cannot be defined.There are too many factors, like screw insertion angle and torque, position of other already present implants, fracture situation, patient condition, especially in relation to bone quality and activity, that could have played a role.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW PANGEA PLATFORM 3.5MM / T15 / L60MM
• Common Device Name: SCREW, 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: 22835359
• Report Number: 0008031020-2025-01390
• Device Sequence Number: 21291578
• Product Code: HWC
• UDI-Device Identifier: 07613327604306
• UDI-Public: (01)07613327604306(10)AJ1774
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 541560
• Device Lot Number: AJ1774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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