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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS PLATE, FIXATION, BONE Back to Search Results
Model Number 71174959
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2020
Event Type  malfunction  
Event Description
It was reported that after a procedure the short depth gauge 2. 4mm/2. 7mm screws tip broke off. No harm or injury reported on patient. Procedure was finished with the same device. No delay reported.
 
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Brand NameSHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS
Type of DevicePLATE, FIXATION, BONE
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
1450 brooks rd.
memphis, TN 38116
5123913905
MDR Report Key10788262
MDR Text Key214723690
Report Number1020279-2020-06164
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71174959
Device Catalogue Number71174959
Device Lot Number14KTRS128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2014
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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