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

Model Number SC2677-35

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 08/03/2016

Event Type  malfunction  

Event Description

Acetabular bone screw bent while inserting into the hole in the acetabular shell.

• 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: 5906512
• MDR Text Key: 53093978
• Report Number: 2530191-2016-00096
• 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: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SC2677-35
• Device Lot Number: 33862260116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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: 58 YR