MAUDE Adverse Event Report: STRYKER GMBH PANGEA PLATFORM LOCKING SCREW 4.0MM / T20 / L50MM; SCREW, FIXATION, BONE

Catalog Number	662250
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) reported the feedback on his second case, in which he implanted a distal medial femur strut and a distal lateral femur strut (dual-plate construct) in presence of prostheses in both the hip and the knee joints (manufacturer(s) of prostheses unknown) his feedback on evaluated aspects is all positive and the following comments were included in the submitted form: "the 4.0 locking screws were difficult to locking into the plate at a variable angle.This has been anissue in the past with the 4.0 locking screws in other pangea large frag plates also." [provided as an additional comment on the product and procedure].
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: PANGEA PLATFORM LOCKING SCREW 4.0MM / T20 / L50MM
• 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: 24739675
• Report Number: 0008031020-2026-00507
• Device Sequence Number: 10191433
• Product Code: HWC
• UDI-Device Identifier: 07613327414226
• UDI-Public: 07613327414226
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 662250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown