MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah EXETER PLUG INTRODUCER; Screw, Fixation, Bone

Catalog Number	0939-0-002M
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: "during the gmrs distal femur procedure, an exeter intramedullary plug was being inserted into femur.The required depth had not yet been reached when the inserter suddenly gave way.Plug introducer was withdrawn, and it was noted that the tip had broken off.The depth was insufficient.The tip plug introducer had penetrated through the femur, a fluoroscopic image was taken.Due to this perforation, the surgeon decided that an extension piece was required to allow the stem to bypass the damaged area.The 17 mm stem that had been prepared was too large after re-cutting, and a smaller one had to be selected.A stryker representative was present in the operating room providing technical support." the femur had to be cut 60 mm more than originally was planned because the surgeon wanted the stem to extend over the penetration point.

• Brand Name: EXETER PLUG INTRODUCER
• Common Device Name: Screw, Fixation, Bone
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Cork; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24936439
• Report Number: 0002249697-2026-00310
• Device Sequence Number: 5356981
• Product Code: HWC
• UDI-Device Identifier: 07613327196047
• UDI-Public: 07613327196047
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153345
• 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): 09/25/2026

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: Health Professional
• Device Catalogue Number: 0939-0-002M
• Device Lot Number: G7639057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Female