MAUDE Adverse Event Report: STRYKER GMBH EXTRA ARTICULAR DISTAL HUMERUS PLATE, R PANGEA HUMERUS PLATING SYSTEM 3.5MM, 130; PLATE, FIXATION, BONE

Catalog Number	540834S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Malposition of Device (2616)
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".
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 device inspection revealed the following: the identification of the returned plate could be confirmed based on the catalog number and lot number marked.The second and fourth most distal universal holes exhibit equal signs of damage, providing consistent evidence that not one, but two screws have pulled through the plate.The threads of both holes are significantly worn and flattened.Furthermore, the deformation observed on the underside of the plate, directly beneath these holes, is consistent with damage caused by 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.The scratches visible on the plate surface occurred most likely during the explantation.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.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 misdrilling, over-torque, or screw angulation outside the minus 15 degree to 15-degree 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.

• Brand Name: EXTRA ARTICULAR DISTAL HUMERUS PLATE, R PANGEA HUMERUS PLATING SYSTEM 3.5MM, 130
• Common Device Name: PLATE, 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: 24051328
• Report Number: 0008031020-2026-00022
• Device Sequence Number: 15819006
• Product Code: HRS
• UDI-Device Identifier: 07613327622539
• UDI-Public: (01)07613327622539(17)340531(10)AH7983
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K242445
• 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
• Device Catalogue Number: 540834S
• Device Lot Number: AH7983
• 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: 01/13/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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