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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF

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SMITH & NEPHEW, INC. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF Back to Search Results
Catalog Number 22-4038
Device Problem Difficult to Fold, Unfold or Collapse (1254)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2020
Event Type  malfunction  
Event Description
It was reported that, during an arthroscopic procedure, the front end of the "firstpass suture passer" did not open smartly after stitching the tissue. The medical staff needed some time and force to open the mouth to leave the joint. The device was bent during that maneuver. The procedure was successfully completed without significant delay using a back-up device. No further complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameDISPOSABLE FIRSTPASS SUTURE PASSER, SELF
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 Key10532487
MDR Text Key206954349
Report Number1219602-2020-01397
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4038
Device Lot Number2053221
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2020
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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