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

Model Number SC2677-40

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

While inserting the bone screw into the acetabular shell, the screw broke.

Manufacturer Narrative

A partial section of the acetabular bone screw was returned for evaluation.This investigation is in process.A review of the device history records showed no material property, mechanical, or dimensional discrepancies existed.

• 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: 4719287
• MDR Text Key: 5583355
• Report Number: 2530191-2015-00009
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC2677-40
• Device Catalogue Number: SC2677-40
• Device Lot Number: 33173250202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2015
• 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 Age: 62 YR