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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE RENEWAL STRYKER AR-13995N @MULTIFIRE SCORPION NDL (BLACK

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MEDLINE RENEWAL STRYKER AR-13995N @MULTIFIRE SCORPION NDL (BLACK Back to Search Results
Catalog Number AR13995NR
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2020
Event Type  malfunction  
Manufacturer Narrative
It was initially reported that the needle broke off into the patient. The needle was retrieved and oem was used. It was further mentioned that this event did not cause harm to the patient. Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details. Due to the reported required medical intervention to retrieve the broken needle, this medwatch is filed. The sample has not been returned. A definitive root cause therefore could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
 
Event Description
It was reported the needle broke off into patient. It was removed and oem used.
 
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Brand NameSTRYKER
Type of DeviceAR-13995N @MULTIFIRE SCORPION NDL (BLACK
Manufacturer (Section D)
MEDLINE RENEWAL
1500 ne hemlock ave
redmond, or
Manufacturer Contact
teresa maynard
three lakes drive
northfield, il 
9311514
MDR Report Key9853274
MDR Text Key190748361
Report Number3032391-2020-00003
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAR13995NR
Device Lot Number423750
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
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 Initial

Patient Treatment Data
Date Received: 03/19/2020 Patient Sequence Number: 1
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