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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SLIDING SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC
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SMITH & NEPHEW, INC. SLIDING SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Catalog Number 7209492
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 12/06/2017
Event Type  malfunction  
Event Description
It was reported that the suture cutter is not functioning.There was no back up available, procedure was completed with competitors device.
 
Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.
 
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Brand Name
SLIDING SUTURE CUTTER
Type of Device
ACCESSORIES,ARTHROSCOPIC
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
MDR Report Key7163475
MDR Text Key96513620
Report Number1219602-2018-00017
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7209492
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/06/2017
Initial Date FDA Received01/04/2018
Supplement Dates Manufacturer Received01/16/2018
Supplement Dates FDA Received01/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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