MAUDE Adverse Event Report: STRYKER GMBH PANGEA PLATFORM LOCKING SCREW 3.5MM / T15 / L28MM; SCREW, FIXATION, BONE

Catalog Number	541528
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a revision surgery had to be performed using synthes.The patient had to have another surgery.The plate failed according to surgeon and a locking screw pulled through the pangea distal humerus plate.A synthes plate was used for the revision".
Additional Manufacturer Narrative
Correction - please refer to h6 device code.The reported event could be confirmed during the investigation.The identification of the returned screw could be confirmed based on the catalog number and lot number marked.The threads at the head of the locking screw have heavily worn out and flattened.The damage observed is a result of post-operative friction between the screw and the plate, confirming the reported screw migration.The returned locking screws and plate were tested.The screws did pass through the two locking holes in question, confirming the reported event.It must be noted that no issue was observed when other plate holes were tested.Due to the damage observed, no accurate dimensional inspection of the screw head was possible.However, the observations from the functional inspection give strong evidence that the screw head dimensions are within specification.It should be noted that more detailed information about the event, as well as x-ray images, would have been necessary to conduct a complete investigation.During manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.The exact root cause of the incident could not be determined.During the device inspection, it was not possible to confirm any user-related error, such as over drilling, over-torque, or screw angulation outside the minus 15 to 15 range, that could explain the incident.However, such factors also cannot be ruled out.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "a revision surgery had to be performed using synthes.The patient had to have another surgery.The plate failed according to surgeon and a locking screw pulled through the pangea distal humerus plate.A synthes plate was used for the revision".

• Brand Name: PANGEA PLATFORM LOCKING SCREW 3.5MM / T15 / L28MM
• 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: 24040240
• Report Number: 0008031020-2026-00023
• Device Sequence Number: 13030432
• Product Code: HWC
• UDI-Device Identifier: 07613327604351
• UDI-Public: (01)07613327604351(10)AH1900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 541528
• Device Lot Number: AH1900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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: 41 YR
• Patient Sex: Male