MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T7 DRIVER SHAFT W/AO QC; SCREWDRIVER

Model Number	71174927
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the t7 driver shaft w/ao qc is not capturing the screw as it used to.No case involved.
Additional Manufacturer Narrative
The devices, intended for use in treatment was returned for evaluation: a visual inspection was performed and confirmed that the shafts appear to be excessively worn, which may cause them to not function as intended.The manufactured date for this device is 2014.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: T7 DRIVER SHAFT W/AO QC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11210686
• Report Number: 1020279-2021-00526
• Device Sequence Number: 16854376
• Product Code: HXX
• UDI-Device Identifier: 00885556387641
• UDI-Public: 00885556387641
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 71174927
• Device Catalogue Number: 71174927
• Device Lot Number: 14JUP0008
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1