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U.S. Department of Health and Human Services

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

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MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHREX SUREFIRE SCORPION NEEDLE; SUTURE PASSER Back to Search Results
Model Number AR-13991N
Device Problem Material Integrity Problem (2978)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 04/15/2016
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation, and the lot number of the failed device could not be determined.Therefore, medline renewal does not have enough information to determine the root cause of the failure.The instructions for use warn the user that the tip of the device may break if excessive force is applied, and that the use of force to pass the needle through fibrous/calcified tissue, or striking bone, can cause needle breakage and patient injury.It is recommended to reposition the needle to pass through a different area.Although the device was not returned for evaluation, medline renewal is filing this medwatch report in an abundance of caution.(b)(4).
 
Event Description
Medline renewal received a report that the tip of a reprocessed arthrex surefire scorpion needle detached during the course of surgery.It is not known if the tip of the needle was retrieved, however the report stated that the patient was not harmed.The device was not returned to medline renewal for evaluation.
 
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Brand Name
MEDLINE RENEWAL REPROCESSED ARTHREX SUREFIRE 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 Key6088126
MDR Text Key59456570
Report Number3032391-2016-00007
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 11/08/2016
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 Physicist
Device Model NumberAR-13991N
Device Catalogue NumberAR-13991N
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/25/2016
Initial Date FDA Received11/08/2016
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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