MAUDE Adverse Event Report: STRYKER GMBH PANGEA PLATFORM LOCKING SCREW 4.0MM / T20 / L38MM; SCREW, FIXATION, BONE

Catalog Number	662238
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "a large fragment pangea peripro interprosthetic plate was used to treat a midshaft periprosthetic femur fracture.Shortly after initial surgery date ((b)(6) 2025), the surgeon noticed the most proximal t20 4.0 pangea locking screw was beginning to back out of the plate.The screw sequentially backed out of the locking mechanism at each post operative visit until the screw fully backed out and slid all the way down to her distal femur".Patient had to be brought back into operating room 16 weeks post operatively to remove backed out hardware (now sitting adjacent to the distal femur).
Additional Manufacturer Narrative
Correction - please refer to: b5 exec summary, d1 product long description, d4 (catalog, lot, gtin #'s), d9 product available to stryker, h6 (method & results) codes.The reported event could be not confirmed, since no x-rays were provided and because the returned screw is not in a condition that would indicate an issue as described in the event description.The device inspection revealed the following: the reported locking screw was returned for evaluation, the affected plate did based on the provided information remain in the patient.The visual inspection has shown that the thread flanks at the shaft are slightly worn, but in retrospective is cannot be defined if this occurred by a slight contact with the peripro plate or with a intramedullary implant that was already present.At the t20 recess are slight deformations, that can be traced back to the screw insertion, visible.The microscopic inspection of the locking thread did show that the thread flanks are in a good condition, with just slight wear marks.There is no indication for an excessive contact with 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.No product related issue could be detected.Without x-rays, that would shown the positioning of the screw, and without the affected plate, that would show the condition of the universal hole, the root cause of this event cannot be defined.There are too many factors, like insertion angle, insertion force or patient related factors in regards to the bone quality or already placed implants that could have played a role.If the also affected plate is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "a large fragment pangea peripro interprosthetic plate was used to treat a midshaft periprosthetic femur fracture.Shortly after initial surgery date ((b)(6) 2025), the surgeon noticed the most proximal t20 4.0 pangea locking screw was beginning to back out of the plate.The screw sequentially backed out of the locking mechanism at each post-operative visit until the screw fully backed out and slid all the way down to her distal femur".Patient had to be brought back into operating room 16 weeks post operatively to remove backed out hardware (now sitting adjacent to the distal femur).

• Brand Name: PANGEA PLATFORM LOCKING SCREW 4.0MM / T20 / L38MM
• 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: 23810453
• Report Number: 0008031020-2025-02159
• Device Sequence Number: 18069334
• Product Code: HWC
• UDI-Device Identifier: 07613327413731
• UDI-Public: (01)07613327413731(10)AL7777
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 662238
• Device Lot Number: AL7777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: 60 YR
• Patient Sex: Female