MAUDE Adverse Event Report: STRYKER GMBH PANGEA HUMERUS PLATING PROXIMAL HUMERUS PLATE, R 3.5MM, 119MM/5 HOLES; PLATE, FIXATION, BONE

Catalog Number	540805S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "using the va drill guide, insert the screw by wiggling it.As the locking fastening failed, the physician attempted to remove the screw to reposition it, but it spun freely and could not be extracted.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and also with provided radiograph was not sufficient.With the available radiograph, a formal medical opinion was sought: based on the provided radiographs, the alleged event cannot be confirmed.The specific screw for the alleged event was also not mentioned.The description stating that the screw was inserted by "wiggling" is unclear and not consistent with standard surgical technique; such a method is neither typical for screw insertion.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "using the va drill guide, insert the screw by wiggling it.As the locking fastening failed, the physician attempted to remove the screw to reposition it, but it spun freely and could not be extracted.".

• Brand Name: PANGEA HUMERUS PLATING PROXIMAL HUMERUS PLATE, R 3.5MM, 119MM/5 HOLES
• 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: 24470487
• Report Number: 0008031020-2026-00248
• Device Sequence Number: 15864003
• Product Code: HRS
• UDI-Device Identifier: 07613327622409
• UDI-Public: (01)07613327622409(17)350731(10)AR5770
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/30/2026

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: 540805S
• Device Lot Number: AR5770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Male