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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 11/10/2020
Event Type  malfunction  
Manufacturer Narrative
Case- (b)(4).
 
Event Description
It was reported that two intertan 3. 2mm guide pin sleeve will not fit into guide anymore. No case involved. Smith and nephew back up device available.
 
Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation. Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions. 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. Based on this investigation, the need for corrective action is not indicated. Without the return of the actual product involved, our investigation could not proceed. Should the device or additional information be received, the complaint will be reopened. No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary. Internal complaint reference number: (b)(4).
 
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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 Key10945550
MDR Text Key219494957
Report Number1020279-2020-06967
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 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674532
Device Catalogue Number71674532
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
Was Device Evaluated by Manufacturer? No
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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