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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 3 8MM; TEMPLATE

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SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 3 8MM; TEMPLATE Back to Search Results
Model Number 00584102308
Device Problem Pitted (1460)
Patient Problem No Patient Involvement (2645)
Event Date 11/03/2020
Event Type  malfunction  
Event Description
It was reported that the articular surface provisional sz 3 8mm presents gouges and pieces coming off of them.No case involved.
 
Manufacturer Narrative
Results of investigation: 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 device is worn with gouges, rendering the device inoperable.The device shows signs of extensive use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.
 
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Brand Name
ARTICULAR SURFACE PROVISIONAL SZ 3 8MM
Type of Device
TEMPLATE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10878119
MDR Text Key217628946
Report Number1020279-2020-06596
Device Sequence Number1
Product Code HWT
UDI-Device Identifier00885556619445
UDI-Public00885556619445
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00584102308
Device Catalogue Number00584102308
Device Lot Number60536935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2020
Initial Date Manufacturer Received 11/03/2020
Initial Date FDA Received11/20/2020
Supplement Dates Manufacturer Received02/19/2021
Supplement Dates FDA Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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