MAUDE Adverse Event Report: STELKAST INC. PROFORM HIP SYSTEM; 6.5MM CANCELLOUS BONE SCREW

Model Number SC2677-40

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned.

Event Description

During a left hip surgery, a 6.5 x 40mm cancellous bone screw broke while being implanted.Only the head of the screw was retrieved.The distal third of the screw remains in the patient.

• Brand Name: PROFORM HIP SYSTEM
• Type of Device: 6.5MM CANCELLOUS BONE SCREW
• Manufacturer (Section D): STELKAST INC.; 200 hidden valley road; mcmurray PA 15317
• Manufacturer (Section G): STELKAST INC.; 200 hidden valley road; mcmurray PA 15317
• Manufacturer Contact: john reyher ; 200 hidden valley road; mcmurray, PA 15317 ; 7249416368
• MDR Report Key: 7128542
• MDR Text Key: 95636474
• Report Number: 2530191-2017-00173
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC2677-40
• Device Lot Number: 33173250202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR