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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE RENEWAL REPROCESSED ARTHREX MULTIFIRE SCORPION NEEDLE; SUTURE PASSER

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MEDLINE RENEWAL REPROCESSED ARTHREX MULTIFIRE SCORPION NEEDLE; SUTURE PASSER Back to Search Results
Model Number AR-13995N
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2017
Event Type  Injury  
Manufacturer Narrative
Although multiple attempts were made to retrieve the device, it was not returned to for evaluation.Therefore we could not confirm if the device was reprocessed.Additionally, the lot number was not provided, therefore a review of the reprocessing records could not be performed.Due to the lack of information surrounding the incident, we do not have enough information to determine the root cause of the failure.If more information is provided then this mdr will be updated.There was no report of an adverse patient consequence or medical intervention as a result of the incident.However, in an abundance of caution, we are filing this medwatch report.Device not returned to manufacturer.
 
Event Description
We received a report indicating that the tip of a reprocessed arthrex multifire scorpion needle, model ar-13995n, detached during use.The physician was not able to retrieve the detached tip.
 
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Brand Name
REPROCESSED ARTHREX MULTIFIRE SCORPION NEEDLE
Type of Device
SUTURE PASSER
Manufacturer (Section D)
MEDLINE RENEWAL
2747 sw 6th st.
redmond OR 97756
Manufacturer (Section G)
MEDLINE RENEWAL
2747 sw 6th st.
redmond OR 97756
Manufacturer Contact
brandi panteleon
2747 sw 6th st.
redmond, OR 97756
5415164180
MDR Report Key6349402
MDR Text Key68031669
Report Number3032391-2017-00003
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberAR-13995N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/23/2017
Initial Date FDA Received02/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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