MAUDE Adverse Event Report: Stryker GmbH PANGEA PLATFORM LOCKING SCREW 5.0MM / T20 / L85MM; Screw, Fixation, Bone

Catalog Number	662385
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported: "plate locking screws became prominent after the locking mechanism uncoupled resulting in a lack of stability and hwr surgery.A single distal lateral locking 5.0 screw was visible underneath the plate surface confirming screw tear thru the locking mechanism of the plate.Unusual performance of the locking plate was questioned by the surgeon and patient was then staged with a static spacer with antibiotics on (b)(6) 2026 and then a dfr scheduled a few days later.However, before the patient's dfr they passed away from post-surgical complications related to general health and optimization.".
Event or Problem Description
It was reported: "plate locking screws became prominent after the locking mechanism uncoupled resulting in a lack of stability and hwr surgery.A single distal lateral locking 5.0 screw was visible underneath the plate surface confirming screw tear thru the locking mechanism of the plate.Unusual performance of the locking plate was questioned by the surgeon and patient was then staged with a static spacer with antibiotics on (b)(6) 2026 and then a dfr scheduled a few days later.However, before the patient's dfr they passed away from post-surgical complications related to general health and optimization.".
Additional Manufacturer Narrative
The reported event could be confirmed, since a displacement of four (4) locking screws could be confirmed based on the pictures received.The device inspection revealed the following: the distal lateral femur plate, five (5) locking screws, one (1) cancellous screw and four (4) cortex screws were returned for evaluation.Based on the provided information was there no issue with the bone screws, therefore are the cortex screws and the cancellous screw considered as concomitant devices.Based on the received x-rays it was possible to identify the three (3) locking screws that backed out of the plate.The returned 85mm, 95mm and 105mm screws are the affected devices.The visual inspection of these screws has shown that all screw heads are slightly damaged in a similar manner, especial the first thread flanks are slightly flattened.This could be an indication for an excessive contact between the screw and the plate during the insertion, for example by an out of the 30° cone insertion.But it can in retrospective 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 currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.No product related issue could be detected during the investigation.Based on investigation, the root cause was most likely attributed to a user related issue, since the visible marks at the also received plate indicate a drilling out of the 30° cone of the predetermined hole trajectory of the universal holes.Due to the damage at the plate was a proper locking of the screw not possible anymore, which contributed to the back out of the three (3) locking screw.However, the exact root cause could not be defined since no pre- and intra-operative x-rays in different planes, operation reports, detailed patient details, history and activity were provided.There are many factors that could have played a role too, like screw insertion torque, fracture situation, patient condition, especially in relation to bone quality and activity.If more information is provided, the case will be reassessed.

• Brand Name: PANGEA PLATFORM LOCKING SCREW 5.0MM / T20 / L85MM
• 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 ; +1(201)831-5000
• MDR Report Key: 25255960
• Report Number: 0008031020-2026-00687
• Device Sequence Number: 20207538
• Product Code: HWC
• UDI-Device Identifier: 07613327414004
• UDI-Public: (01)07613327414004(10)AP4239
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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 Catalogue Number: 662385
• Device Lot Number: AP4239
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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: Death; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male