MAUDE Adverse Event Report: PROVISION ARTHREX; PASSER

Model Number AR-13995N

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/15/2021

Event Type  malfunction  

Event Description

Needle multi-fire scorpion tip broke off during surgery, this is the second time it has happened, surgeon did do x-rays at the end of the case.Per the attending surgeon's operating room note: i noticed the tip of the suture passer was missing and broken off.I did a thorough arthroscopic intraoperative examination of the shoulder, and did not find or see it.  intraoperative as well postoperative x-rays were obtained, neither of which revealed a foreign body.This leads me to believe that this broke off outside of the shoulder, or was removed via the suction tubing.

• Brand Name: ARTHREX
• Type of Device: PASSER
• Manufacturer (Section D): PROVISION; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 11789803
• MDR Text Key: 249448906
• Report Number: 11789803
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2021,04/19/2021

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: No Information
• Device Model Number: AR-13995N
• Device Catalogue Number: AR-13995N
• Device Lot Number: 12534705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA