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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the needle was broken during use. No patient injuries or significant delay were reported. Back-up device was available to complete the surgery. All the broken pieces were removed from the patient's anatomy.
 
Manufacturer Narrative
Two disposable meniscus mender ii kits were returned for evaluation. The product storage cradles and needles were not returned for examination. Visual assessment of the kits confirmed all of the suture loops shafts have broken where they interface with their handles. 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 Key8566926
MDR Text Key143683298
Report Number1219602-2019-00489
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier03596010468482
UDI-Public03596010468482
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K885311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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 Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7209485
Device Lot Number50754287
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2019
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
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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