MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE, R PANGEA FEMUR PLATING SYSTEM 5.0MM, 337MM/14 HOLES; PLATE, FIXATION, BONE

Catalog Number	540184S
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that "the sales rep received the order about pangea left df plate from the dr.(b)(6) on december 5.However, the sales rep ordered not left but right plate by mistake.During the surgery on december 10, whilst checking the implant devices in the operating room, the sales rep noticed right plate was ordered by mistake and reported this to the doctor.As arranging the correct plate also takes time, the surgery was cancelled and postponed to friday 12th december while the patient had begun to receive anaesthesia but had not yet been fully anaesthetised.The reported issue was human error and there was no product defect reported.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 event was reported.Based on the available information, the incident can be attributed to an individual error that unfortunately was not detected as intended before the operation.In this context, we would like to once again emphasize the pangea femur plating system instruction for use (700003311446 rev aa, 12-2024) with the following statement: the instructions for use (pangea femur plating system;) were reviewed: "caution ensure that all components needed for the operation are available in the operation theatre." if more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that "the sales rep received the order about pangea left df plate from the dr.(b)(6) on (b)(6).However, the sales rep ordered not left but right plate by mistake.During the surgery on (b)(6), whilst checking the implant devices in the operating room, the sales rep noticed right plate was ordered by mistake, and reported this to the doctor.As arranging the correct plate also takes time, the surgery was cancelled and postponed to friday (b)(6) while the patient had begun to receive anaesthesia but had not yet been fully anaesthetised.The reported issue was human error and there was no product defect reported.".

• Brand Name: DISTAL LATERAL FEMUR PLATE, R PANGEA FEMUR PLATING SYSTEM 5.0MM, 337MM/14 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: 23875446
• Report Number: 0008031020-2025-02213
• Device Sequence Number: 5571132
• Product Code: HRS
• UDI-Device Identifier: 07613327609714
• UDI-Public: 07613327609714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/06/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 540184S
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/06/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female