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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW TAP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. LAG SCREW TAP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674009
Device Problems Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Event Description
It was reported that, during a trauma procedure, it was noticed that the following instruments of the trigen¿ intertan¿ instrument set are warped due to wear and tear over past 3 years: lag screw drill sleeve (case-(b)(4)), intertan 3. 2mm guiide pin sleeve (case-(b)(4)), lag screw tap (case-(b)(4)), lag screw driver (case-(b)(4)), compression screw hexdriver (case-(b)(4)), subtroc lag screw driver (case-(b)(4)), 130 rad drill gde drop (case-(b)(4)), unknown trigen instrument (case-(b)(4)), unknown trigen instrument (case-(b)(4)). The procedure was able to be completed with the same device. Surgery was greater than 30-mins delayed. Patient was not harmed.
 
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Brand NameLAG SCREW TAP
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 Key11853760
MDR Text Key251655087
Report Number1020279-2021-04512
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674009
Device Catalogue Number71674009
Device Lot Number07KHU0011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/03/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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