MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER; SCREWDRIVER

Model Number	71175077
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Event or Problem Description
It was reported that the tines of six evos small t8 fixed handle linear driver are rounded off.No case involved.
Additional Manufacturer Narrative
The information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that the device's malfunction was material deformation (the tines are rounded off), which has not caused or contributed to death or serious injury, and has not necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, and could not cause such harm if the failure were to recur in future.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference number: (b)(4) the information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that the device's malfunction was material deformation (the tines are rounded off), which has not caused or contributed to death or serious injury, and has not necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, and could not cause such harm if the failure were to recur in future.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference number: (b)(4).

• Brand Name: EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER
• Common Device Name: 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 Key: 13925079
• Report Number: 1020279-2022-01343
• Device Sequence Number: 15015404
• Product Code: HXX
• UDI-Device Identifier: 00885556636077
• UDI-Public: 00885556636077
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 71175077
• Device Catalogue Number: 71175077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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