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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ALIGNMENT ARM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. ALIGNMENT ARM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674066
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2021
Event Type  malfunction  
Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated. A visual inspection of the returned device confirmed the stated failure mode. The returned device is fractured rendering the device inoperable. The device was manufactured in 2007 and shows signs of extensive use. A review of complaint history did not reveal additional complaints for the listed batch. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture. This device is a reusable instrument that can be exposed to numerous surgeries. 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. Should additional information be received, the complaint will be reopened. No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary. We consider this investigation closed. (b)(4).
 
Event Description
It was reported that an alignment arm was cracked. It was discovered after cleaning when it was being reassembled. No case reported; therefore, there was no patient involvement. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameALIGNMENT ARM
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 Key11478029
MDR Text Key239618417
Report Number1020279-2021-02016
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674066
Device Catalogue Number71674066
Device Lot Number07FSP0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2007
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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