MAUDE Adverse Event Report: STRYKER GMBH 3.5 STRAIGHT NARROW PLATE PANGEA UTILITY PLATING SYSTEM 3.5MM, 104MM/7 HOLES; PLATE, FIXATION, BONE

Catalog Number	541037
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	09/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the products in question are the 3.5mm narrow compression plate t15, (541037 7 hole plate for example) and the shorter t15 cortical screws (661412 12mm screw for example).I watched the surgeon drill through both cortices once using the va guide (542028) in what looked like a perpendicular to the plate trajectory.We confirmed it was a 2.5mm drill used.The screw would continue to spin in the hole upon insertion, this happened twice.We then used a longer screw and the same happened again.The surgeon thinks it's because the pitch of the screws are inferior and hence on smaller lengths they don't get as good as purchase as what he uses.Another comment was that the screw head looked too small compared to the dcp hole.This was a problem when a screw was inserted on an angle away from the fracture site.The surgeon found that upon tightening the cortical screw in this trajectory that the space between the screw head and the bottom of the plate was very low and he was worried about screw pull through on the plate.".

• Brand Name: 3.5 STRAIGHT NARROW PLATE PANGEA UTILITY PLATING SYSTEM 3.5MM, 104MM/7 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: 23639301
• Report Number: 0008031020-2025-02101
• Device Sequence Number: 21146855
• Product Code: HRS
• UDI-Device Identifier: 07613327606522
• UDI-Public: 07613327606522
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K231257
• 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): 11/24/2025

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
• Device Catalogue Number: 541037
• 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: 10/28/2025
• Initial Report FDA Received Date: 11/24/2025
• 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
• Patient Sex: Male