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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 Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2021
Event Type  malfunction  
Manufacturer Narrative
The device, used in treatment, was returned for evaluation. A visual inspection of the returned device confirmed the stated failure mode. The retention ball is missing, rendering the device inoperable. The device was manufactured in 2014 and shows signs of extensive use. A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode. A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident. This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur. Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event. We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. Based on this investigation, the need for corrective action is not indicated. Should additional information be received, the complaints will be reopened. No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.
 
Event Description
It was reported that the during an unspecified procedure the intertan 3. 2mm guide pin sleeve will not capture into the lag screw drill sleeve. No harm or delay occurred. Sn backup was available.
 
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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 Key11256295
MDR Text Key229592376
Report Number1020279-2021-00775
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
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674532
Device Catalogue Number71674532
Device Lot Number14MM16191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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