MAUDE Adverse Event Report: SMITH+NEPHEW LYON CANNULATED SCREWDRIVER

Model Number	129733ND
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, during plate and screws removal surgery, two teeth on a cannulated screwdriver broke when trying to remove screws and plate.This was due to the plate and screw being well fixed.However, this didn¿t affect the outcome of the surgery and the screws and plate were successfully removed.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The product was returned on (b)(6) 2023.We perform a visual inspection that confirmed the issue described on this complaint.There is a missing pin.We perform also analysis referring to the associated inspection work instruction.All results met the requirements except the missing pin.The involved product is from manufacturing lot e4yx and was manufactured in (b)(6) 2007.Root cause analysis.The following investigative actions were performed.Refer to the respective tasks for further detail.Complaint history review: the complaint history review does not identify any previous similar reported event for this device and none for the same manufacturing lot.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Medical investigation monitoring board (mimb) review: per mimb, a medical investigation was not required.The complaint alleges no injury to the patient.It could not be determined whether the device contributed to the reported event.Following the analysis of the returned product, normal wear (product used during more than 15 years) is identified as failure mode which could result in breakage of the teeth of the hallu fix driver.Based on this investigation, the need for corrective action is not indicated as no non-conformances or product deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• Brand Name: CANNULATED SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH+NEPHEW LYON; immeuble sequoia 2; saint priest rhone 69800 ; FR 69800
• Manufacturer (Section G): SMITH+NEPHEW LYON; immeuble sequoia 2; saint priest rhone 69800 ; FR 69800
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16479752
• Report Number: 3002952164-2023-00002
• Device Sequence Number: 12612691
• Product Code: HXX
• UDI-Device Identifier: 10381780052197
• UDI-Public: 10381780052197
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 129733ND
• Device Catalogue Number: 129733ND
• Device Lot Number: E4YX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown