MAUDE Adverse Event Report: STRYKER GMBH DISTAL ANTEROLATERAL TIBIA PLATE, R PANGEA TIBIA PLATING SYSTEM 2.7/3.5MM, 189MM; PLATE, FIXATION, BONE

Catalog Number	540530
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the surgeon was using plate 540530 (right 10 hole pangea distal anterolateral plate) when the incident occurred.The he drilled the hole using the variable angle drill guide.Once he placed the screw, it went below the screw hole (3.5 locking screw in a 3.5mm hole) and became stuck.He tried multiple times to remove the screw, but unfortunately was unable.He ended up having to use the midas rex to remove the screw.".
Additional Manufacturer Narrative
The device will not be returned.When additional information becomes available, it will be provided in a supplemental report.

• Brand Name: DISTAL ANTEROLATERAL TIBIA PLATE, R PANGEA TIBIA PLATING SYSTEM 2.7/3.5MM, 189MM
• 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: 23317239
• Report Number: 0008031020-2025-01937
• Device Sequence Number: 17356493
• Product Code: HRS
• UDI-Device Identifier: 07613327611748
• UDI-Public: 07613327611748
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/16/2025

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: Health Professional
• Device Catalogue Number: 540530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/16/2025
• 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: Unknown