MAUDE Adverse Event Report: SMITH+NEPHEW LYON SCREWDRIVER TORX T7

Model Number	219127ND
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the head of an screwdriver torx t7 was missing.The instrument cannot be used anymore because it does not fit securely into the head of the screws.As this was noticed after surgery, and it was confirmed that the breakage did not occur while in use, there was not patient involvement.
Additional Manufacturer Narrative
H3, h6: the product has been received at the lyon site for evaluation and so the complaint is confirmed.A visual inspection at receipt confirmed the breakage of the hexalobular tip of the screwdriver.It is observed that the tip is twisted at the location of the breakage.It means that a plastic deformation of the tip occurred prior to the breakage and is due to the application of a stress superior to the mechanical resistance of the device.No other anomaly is observed.The following investigative actions were performed.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identify two previous similar reported event for this device and the second for the same product 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.According to risk management documentation for the hallulock instruments, application of excessive mechanical forces, improper check prior to the use or improper raw material are identified as failure mode which could result in breakage of the hallu lock 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: SCREWDRIVER TORX T7
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH+NEPHEW LYON; immeuble sequoia 2; 97 alle alexandre borodine.; saint priest rhone 69800 ; FR 69800
• Manufacturer (Section G): SMITH+NEPHEW LYON; immeuble sequoia 2; 97 alle alexandre borodine.; saint priest rhone 69800 ; FR 69800
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15093863
• Report Number: 3002952164-2022-00013
• Device Sequence Number: 14742682
• Product Code: HXX
• UDI-Device Identifier: 10381780052227
• UDI-Public: 10381780052227
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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: 219127ND
• Device Catalogue Number: 219127ND
• Device Lot Number: FTL6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown