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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS GAUGE, DEPTH

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SMITH & NEPHEW, INC. DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS GAUGE, DEPTH Back to Search Results
Model Number 71174928
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that, the tip of the depth gauge for 2. 4mm and 2. 7mm screws was found during inspection bent and broken, rendering it unusable. There was no patient involvement.
 
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Brand NameDEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13056611
MDR Text Key282613780
Report Number1020279-2021-08773
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71174928
Device Catalogue Number71174928
Device Lot Number14KTRS124
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/29/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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