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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MIS 3.2MM X 45MM RIMMED PIN STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. MIS 3.2MM X 45MM RIMMED PIN STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 74016465
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2023
Event Type  malfunction  
Manufacturer Narrative
H10: internal complaint reference: (b)(4).
 
Event Description
It was reported that, during tka surgery, one (1) mis 3.2mm x 45mm rimmed pin sterile broke off while screwing through the block.The pin was removed.The procedure was resumed, using a s+n back-up device.It is unknown if there was any delay.No injury was reported as a consequence of this issue.
 
Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should the device or 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
MIS 3.2MM X 45MM RIMMED PIN STERILE
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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 Key16759030
MDR Text Key313863930
Report Number1020279-2023-00856
Device Sequence Number1
Product Code HSX
UDI-Device Identifier00885556691984
UDI-Public885556691984
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/17/2023
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 Catalogue Number74016465
Device Lot Number21BNX0108
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2023
Initial Date FDA Received04/18/2023
Supplement Dates Manufacturer Received05/16/2023
Supplement Dates FDA Received05/17/2023
Date Device Manufactured09/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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