MAUDE Adverse Event Report: STELKAST INC. SCREW DRIVER HANDLE

Model Number SC1349

Device Problem Device Issue (2379)

Patient Problem Missing Value Reason (3192)

Event Date 09/10/2015

Event Type  malfunction  

Event Description

During surgery the screw driver handle would not ratchet.While attempting to turn it, the ratchet detached from the handle.The surgeon requested another driver and the surgery continued without incident.

• Brand Name: SCREW DRIVER HANDLE
• Type of Device: SCREW DRIVER HANDLE
• 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: 5127384
• MDR Text Key: 27691549
• Report Number: 2530191-2015-00037
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC1349
• Device Catalogue Number: SC1349
• Device Lot Number: SO40638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1