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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET SCREW DRIVER; SCREWDRIVER

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SMITH & NEPHEW, INC. SET SCREW DRIVER; SCREWDRIVER Back to Search Results
Catalog Number 71665014
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Manufacturer Narrative
H10: internal complaint reference: (b)(4).
 
Event Description
It was reported that during surgery the portion of the set screw driver which passes through the joint fell apart.All pieces were visualized and retrieved from the patient.Surgeon confirmed that no pieces were left via fluroscopy.It is unknown if there was any delay.No patient injury reported.
 
Manufacturer Narrative
H6: the device was not returned for evaluation; therefore, a device analysis could not be performed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, 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 evidence to conclude that the product failed to meet any 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 potential factors that could contribute to 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 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.
 
Manufacturer Narrative
G4: date received by manufacturer.New information was received, with a confirmation of the aware date.Sales representative was not present during surgery, and no smith and nephew employee was aware of this event until the medwatch mas received.Therefore, our aware date is february 28th, 2024.
 
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Brand Name
SET SCREW DRIVER
Type of Device
SCREWDRIVER
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 Key18813632
MDR Text Key336648428
Report Number1020279-2024-00460
Device Sequence Number1
Product Code HXX
UDI-Device Identifier03596010518989
UDI-Public03596010518989
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup
Report Date 04/18/2024
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 Number71665014
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/29/2024
Supplement Dates Manufacturer Received02/28/2024
04/17/2024
Supplement Dates FDA Received03/05/2024
04/18/2024
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 Unknown
Patient Sequence Number1
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