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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE RENEWAL ARTHREX SUTURELASSO¿ SD, 90 DEGREES UP (BLACK) 1.8MM

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MEDLINE RENEWAL ARTHREX SUTURELASSO¿ SD, 90 DEGREES UP (BLACK) 1.8MM Back to Search Results
Catalog Number AR406890RH
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that during an unknown procedure, the tip of the reprocessed arthrex suturelasso sd, 90 degrees up (black) 1. 8mm, broke off into patient. The tip of the device was reportedly retrieved from the surgical site through an unknown method. There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to the incident. Due to the reported device failure and the required intervention to retrieve the device tip that broke off into patient, this medwatch is being filed. The sample is not available to be returned for evaluation. A review of the device history record for the reported lot number was performed and this review indicated that all processes were conducted as required at the time the lot was processed. A definitive root cause for the reported issue could not be determined at this time. No additional information is available. If additional relevant information becomes available, a supplemental medwatch will be filed.
 
Event Description
It was reported that the tip of the reprocessed arthrex suturelasso sd broke off into patient.
 
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Brand NameARTHREX
Type of DeviceSUTURELASSO¿ SD, 90 DEGREES UP (BLACK) 1.8MM
Manufacturer (Section D)
MEDLINE RENEWAL
1500 ne hemlock ave
redmond OR 97756
Manufacturer Contact
stephen wilson
1500 ne hemlock ave
redmond, OR 97756
MDR Report Key9376344
MDR Text Key190132842
Report Number3032391-2019-00029
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAR406890RH
Device Lot Number421796
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
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: 11/26/2019 Patient Sequence Number: 1
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