MAUDE Adverse Event Report: STRYKER IRELAND OSTEONICS STRYKER FLEXIBLE/FIXED HEAD BIXCUT REAMER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 0227-6110

Device Problems Break (1069); Mechanical Problem (1384); Material Too Soft/Flexible (4007)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2021

Event Type  Injury  

Event Description

Multiple graduated sized reamers are needed to prepare the intramedullary canal for receiving an orthopedic rod or nail.During a procedure to repair a left comminuted femoral shaft fracture, while reaming for the im nail, the flexible reamer broke in the femoral canal.The reamer was too flexible and would not rotate nor could be malleted out.The surgeon needed to take an alternate approach for retrieval.Fda safety report id# (b)(4).

• Brand Name: STRYKER FLEXIBLE/FIXED HEAD BIXCUT REAMER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER IRELAND OSTEONICS
• MDR Report Key: 11824815
• MDR Text Key: 250831477
• Report Number: MW5101338
• Device Sequence Number: 1
• Product Code: MAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0227-6110
• Device Catalogue Number: 0227-6110
• Device Lot Number: KOLE9A2 OR KOEE9A2
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 79