MAUDE Adverse Event Report: ARTHREX POINT TO POINT CLAMP; ACCESSORIES, ARTHROSCOPIC - VARIOUS

Model Number AR160FT

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

While using a point to point clamp the tip broke off and it is believed to have gone off the operative table.We were able to locate the tip.The tip was located placed in a plastic bag and was sent to sterile processing.

• Brand Name: POINT TO POINT CLAMP
• Type of Device: ACCESSORIES, ARTHROSCOPIC - VARIOUS
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 7352177
• MDR Text Key: 103005629
• Report Number: MW5075958
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR160FT
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR