MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS STRYKER ORTHOPAEDICS; REAMER 24MM

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/07/2022

Event Type  Injury  

Event Description

During a hip replacement procedure, a stryker reamer became lodged in the pt's femoral canal.An osteotomy was performed to dislodge the reamer and prevent further injury.

• Brand Name: STRYKER ORTHOPAEDICS
• Type of Device: REAMER 24MM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS
• MDR Report Key: 14621151
• MDR Text Key: 294779540
• Report Number: 14621151
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2022
• Distributor Facility Aware Date: 05/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White