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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET MENISCUS MENDER II DISPOSABLE PASSER

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SMITH & NEPHEW, INC. SET MENISCUS MENDER II DISPOSABLE PASSER Back to Search Results
Catalog Number 7209485
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure, a jelcos was passed with an ultrabraid and then a jelco was passed to rescue the suture, the handle of the meniscus mender was introduced inside the jelco, the ultrabraid was rescued through the handle; on the monitor was showed that the handle was completely loose from the base. The handle of the patient's joint was removed in its entirety. No patient injuries were reported.
 
Manufacturer Narrative
One (b)(4) disposable meniscus mender ii set returned. The complaint stated: ¿the handle was completely loose from the base. ¿ all components are present. The braided loops themselves are damaged. The inserter shaft portion of the loop components are bent. One braid has been severed from its distal tip. The spinal needles are bent and bowed. To keep components from shifting within the package, the product storage cradles are intentionally snug. The heads of the braided loop components snap into their cavities to avoid inadvertent loop disturbance during removal from their cradles. Using the distal end (head) to removal a loop from the tray can result in bending or complete fracture between the head and shaft. The most successful method of retrieval is to push the head of the component from the back of the cradle to pop it free. Recent engineering evaluation confirmed this product meets specifications. Occurrence of allegations are monitored via surveillance. Correction in: health professional: yes occupation: other_health_care_professional health professional should be marked, company representative: should not be marked. Additional information in : address line 1: (b)(4). Foreign city: (b)(4).
 
Event Description
It was reported that during a procedure, a jelcos was passed with an ultrabraid and then a jelco was passed to rescue the suture, the handle of the meniscus mender was introduced inside the jelco, the ultrabraid was rescued through the handle; on the monitor was showed that the handle was completely loose from the base. Delay more that 30 minutes was reported. The handle was completely removed from the patient¿s joint. No patient injuries were reported.
 
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Brand NameSET MENISCUS MENDER II DISPOSABLE
Type of DevicePASSER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 w william cannon drive
austin, TX 78735
5123585706
MDR Report Key8316991
MDR Text Key135702923
Report Number1219602-2019-00160
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K885311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7209485
Device Lot Number50694645
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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