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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.
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Type of DevicePASSER
Manufacturer (Section D)
1370 creekside blvd
naples FL 34108
MDR Report Key11789803
MDR Text Key249448906
Report Number11789803
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAR-13995N
Device Catalogue NumberAR-13995N
Device Lot Number12534705
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2021
Event Location Hospital
Date Report to Manufacturer05/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown