MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW PANGEA PLATFORM 5.0MM / T20 / L50MM; SCREW, FIXATION, BONE

Catalog Number	662350
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a pangea distal femur plate was placed on (b)(6) 2025 there was a revision case done on (b)(6) 2025 where it showed multiple 5.0 locking screws going through the plate hole.Lateral x-ray from the previous surgery showed that the screws didn¿t miss the plate in the initial surgery.The plate malfunction result in a revision surgery where multiple screws were removed from the plate and a retrograde nail was placed.".
Additional Manufacturer Narrative
Although it cannot be determined at this time which of the reported screws pulled through the plate, a list of the devices used is noted below: catalog: lot: qty: 661755.Ah6442.1.662330.Aj1041.1.662350.Unknown.1.662350.Aj7134.1.662375.Ak1914.3.662380.Aj2418.1.662385.Ak1002.1.Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a pangea distal femur plate was placed on (b)(6) 2025 there was a revision case done on (b)(6) 2025 where it showed multiple 5.0 locking screws going through the plate hole.Lateral x-ray from the previous surgery showed that the screws didn't miss the plate in the initial surgery.The plate malfunction result in a revision surgery where multiple screws were removed from the plate and a retrograde nail was placed.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the reported screw migration is visible on the received x-rays as described in the event description.The device inspection revealed the following: the evaluation of both 50mm locking screws has shown that the thread flanks at the locking thread are damaged.The damages indicate that there was a in-situ movement between the screw head and the plate.It is clear that the damage is only present on one side of the screw heads.This suggests that the screw head of both screws did not go through the plate, because otherwise the head would be damaged all around.Based on this finding it is very likely that the returned screws are the screws which did back out on the x-rays.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.The complaint and the received x-rays were reviewed by medical affairs and lifecyle management with following conclusion: there was no x-ray provided which shows the complete construct in one view.On one x-ray (pangea plate set 3) are four migrated locking screws in the shaft of the femur visible.The most distal and the most proximal screw are backed out while the two screws between the backed out screws were pulled through the plate.All the affected screws in the shaft area have about the same length of around 50mm.But only two screws in this length range were returned for evaluation, the other screws are either much shorter (30mm) or longer (75mm).This means two of the affected screws, including the initially reported catalog # 662346 and as well the affected plate is missing.During the evaluation of the x-rays, it appeared that two of the displaced screws were too small and therefore may not have been held in place in the universal holes of the plate.This impression is particularly evident in the ap view (pangea plate set 5), where it appears that the screws have different diameters, and also in the lateral view (pangea plate set 4), where it appears that the head diameters of the screws are too small in comparison to the plate holes.Ultimately, without images of the entire construct, information about the patient's activities, and having all affected devices back for evaluation, it is not possible to determine the final cause of the reported event.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW PANGEA PLATFORM 5.0MM / T20 / L50MM
• 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: 23211612
• Report Number: 0008031020-2025-01659
• Device Sequence Number: 9019491
• Product Code: HWC
• UDI-Device Identifier: 07613327416015
• UDI-Public: (01)07613327416015(10)AJ7134
• 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): 12/18/2025

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: 662350
• Device Lot Number: AJ7134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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: 58 YR
• Patient Sex: Female