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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS SUTURE PASSER SELF-CAPTURE; ACCESSORIES,ARTHROSCOPIC
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SMITH & NEPHEW, INC. TRUEPASS SUTURE PASSER SELF-CAPTURE; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Catalog Number 72203791
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2015
Event Type  malfunction  
Manufacturer Narrative
Visual examination of the device showed no damage.The device was functionally tested with a new needle and the device performed with no issue.The needle picked up the suture on several consecutive passes.Reported complaint could not be confirmed or replicated.No root cause related to the manufacturing process can be established.
 
Event Description
It was reported that during a procedure using a truepass suture passer, the tip of the needle broke off.There were no patient injuries or surgical complications reported as a result of this event.
 
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Brand Name
TRUEPASS SUTURE PASSER SELF-CAPTURE
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
Manufacturer Contact
jim gonzales
7000 w william cannon dr.
andover, TX 01810
5123585706
MDR Report Key5964596
MDR Text Key55441658
Report Number1219602-2016-00755
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 03/27/2015
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 Number72203791
Device Lot Number28937
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2015
Initial Date Manufacturer Received 03/27/2015
Initial Date FDA Received09/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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