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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
Model Number 7209485
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Event Description
It was reported that during an arthroscopy, the small holding knob at the back of both looped wire of the meniscal menders broke off when they were handled and manipulated by the surgeon. The procedure was completed with a competitor device. There was a delay greater than 30mins and no other complications were reported.
 
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Brand NameSET MENISCUS MENDER II DISPOSABLE
Type of DevicePASSER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11810526
MDR Text Key250180649
Report Number1219602-2021-01101
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeSF
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 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7209485
Device Catalogue Number7209485
Device Lot Number2061324
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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