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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 Problems Break (1069); Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during meniscoplasty, there was a dissociation of the lasso of its basis inserting it inside the barrel, it was not correctly crimped (there was a black line between the metal base and the stem and at the time of the use the device broke off at the level of black line. ). The procedure was completed with a backup device with no patient injuries or significant delay. Everything has been removed from the patient.
 
Manufacturer Narrative
Two suture loop components from a meniscus mender ii set were returned for evaluation. Visual assessment of the devices confirmed the reported complaint of breakage. The tubing has broken were it interfaces with the handle at the weldment. A trend of this nature has been observed with this product in the field, prompting a root cause investigation. This investigation is ongoing.
 
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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 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8545293
MDR Text Key143045687
Report Number1219602-2019-00465
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier03596010468482
UDI-Public03596010468482
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K885311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7209485
Device Lot Number50780575
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2019
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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