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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROVISION ARTHREX PASSER

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PROVISION ARTHREX PASSER Back to Search Results
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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Brand NameARTHREX
Type of DevicePASSER
Manufacturer (Section D)
PROVISION
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

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