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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR; SCREWDRIVER

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SMITH & NEPHEW, INC. EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR; SCREWDRIVER Back to Search Results
Catalog Number 71175072
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2023
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Event Description
It was reported that, during an internal fixation surgery, the tip of an evos sm 2.5mm fixed handle linear hex dr has broken off, no pieces fell inside the wound, all the broken pieces were removed with tweezers and accounted.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
 
Event Description
It was reported that, during an internal fixation surgery, the tip of an evos sm 2.5mm fixed handle linear hex dr has broken off.All the broken pieces were removed with tweezers and accounted.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
 
Manufacturer Narrative
H6: (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation.However, the photograph was reviewed, and revealed that the tip of the device fractured.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 based on the historical data revealed similar events for the listed batch, 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 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.Corrected data: b5: (narrative updated), h6: (health effect - impact code).
 
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Brand Name
EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR
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 Key18075143
MDR Text Key327426100
Report Number1020279-2023-02151
Device Sequence Number1
Product Code HXX
UDI-Device Identifier00885556636046
UDI-Public00885556636046
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/30/2023
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 Number71175072
Device Lot Number18GUP0002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2023
Initial Date FDA Received11/06/2023
Supplement Dates Manufacturer Received11/22/2023
Supplement Dates FDA Received11/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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