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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4MM TROCAR DRILL SLEEVE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. 4MM TROCAR DRILL SLEEVE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631026
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2021
Event Type  malfunction  
Event Description
It was reported that a 4mm trocar drill sleeve is jamming. As this was noticed upon field inspection, there was not patient involvement.
 
Manufacturer Narrative
Internal reference number: (b)(4).
 
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Brand Name4MM TROCAR DRILL SLEEVE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
austin, TX 78735
5123913905
MDR Report Key12865719
MDR Text Key281205671
Report Number1020279-2021-08354
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71631026
Device Catalogue Number71631026
Device Lot Number20JM02046
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2020
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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