MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW PANGEA PLATFORM 5.0MM / T20 / L55MM; SCREW, FIXATION, BONE

Catalog Number	662355
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the most proximal locking screw in the peripro intraprostatic plate pulled through the plate.This was noticed on a follow up x-ray and the plate and screw were removed.
Event or Problem Description
It was reported that the most proximal locking screw in the peripro interprostetic plate pulled through the plate.This was noticed on a follow up x-ray and the plate and screw were removed.
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned screw could be confirmed based on the catalog # and the lot # marked.The threads of the locking screw are highly worn out and deformed.The damage observed coincides with the event reported.Therefore, it could be confirmed that one locking screw pulled through the plate.Post-operative x-ray images were received for inspection.The plate was used in conjunction with an intramedullary nail to treat a subtrochanteric femoral fracture.This corresponds to the intended use of the implant.However, the plate was also used for femoral neck stabilization, as proximal screws were implanted inside the neck.This is an off-label use, as pangea peripro femoral plates are not intended for this type of fixation.It has been confirmed by r&d that: "the plate is not intended to be used for this indication.Finally was the fixation with just three screws at both ends of the plate not strong enough, which did to the pull out of the screw." based on investigation, the root cause was attributed to an user related issue.The plate was not used as indicated and was implanted with too few screws, which caused a lack of stabilization of the construct and the migration of the one of the proximal locking screws.As a reminder the instructions for use and the operative technique clearly state that: "the licensed healthcare professional (hcp) and operating room team must be thoroughly familiar with the operating technique, the instruments, as well as the range of implants to be applied.Complete information and labeling on these subjects must be readily available at the workplace." "the peripro femur plating system is also contraindicated for femoral neck fractures treated standalone".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: LOCKING SCREW PANGEA PLATFORM 5.0MM / T20 / L55MM
• 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: 21985253
• Report Number: 0008031020-2025-00871
• Device Sequence Number: 8480186
• Product Code: HWC
• UDI-Device Identifier: 07613327415681
• UDI-Public: (01)07613327415681(10)AK4277
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K242445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 662355
• Device Lot Number: AK4277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: 27 YR
• Patient Sex: Male