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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ASSEMBLY ENDOBUTTON INDICATOR GAUGE, DEPTH

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SMITH & NEPHEW, INC. ASSEMBLY ENDOBUTTON INDICATOR GAUGE, DEPTH Back to Search Results
Model Number 72202544
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference case: (b)(4).
 
Event Description
It was reported that during ligamentoplasty, the screw that allows the measurement scale to be placed on the meter body was placed backwards in the manufacturing process, which makes it impossible to measure the length of the femoral tunnel when preparing it in the surgical procedure. There was a change in surgical technique and no significant delay or other 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 NameASSEMBLY ENDOBUTTON INDICATOR
Type of DeviceGAUGE, DEPTH
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 Key10947411
MDR Text Key219852061
Report Number1219602-2020-01991
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72202544
Device Catalogue Number72202544
Device Lot Number50854863
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 Received05/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/13/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/04/2020 Patient Sequence Number: 1
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