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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 3.2MM GUIIDE PIN SLEEVE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. INTERTAN 3.2MM GUIIDE PIN SLEEVE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674532
Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Event Description
It was reported that the intertan 3. 2mm guide pin sleeve and the lag screw drill sleeve were bent and had to be removed from each other with a mallet. No case involved.
 
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Brand NameINTERTAN 3.2MM GUIIDE PIN 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, TX 78735
5123913905
MDR Report Key11909155
MDR Text Key253612303
Report Number1020279-2021-04836
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
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 07/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674532
Device Catalogue Number71674532
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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