MAUDE Adverse Event Report: STELKAST INC. PROFORM HIP SYSTEM; ACETABULAR BONE SCREW

Model Number SC2677-30

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.A review of the device history records showed no material property, mechanical, or dimensional discrepancies existed.

Event Description

During hip surgery, the surgeon drilled for a 30mm acetabular bone screw.During insertion of the screw, the head of the bone screw broke off.Another hole in the acetabular shell was used and a 25mm screw was successfully inserted.

• Brand Name: PROFORM HIP SYSTEM
• Type of Device: ACETABULAR 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: 7659330
• MDR Text Key: 113163826
• Report Number: 2530191-2018-00050
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• 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: 07/03/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SC2677-30
• Device Lot Number: 40280271203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2017
• 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 Age: 70 YR