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

Model Number	71175077
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the t8 fixed handle driver is stripping the screw head.The event occurred during use, with instruments inside the patient.The procedure was completed with a change in surgical technique, using a modular screwdriver.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, there is no evidence to support the implantation of the screw was not successful.According to the report, the procedure completed with a change in the surgical technique using a modular screw.Since there was no surgical delay or injury to the patient, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint will be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product 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 probable causes of 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.Without the return of the actual product involved, our investigation could not proceed.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.

• 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
• MDR Report Key: 10956308
• Report Number: 1020279-2020-07041
• Device Sequence Number: 3189551
• Product Code: HXX
• UDI-Device Identifier: 00885556636077
• UDI-Public: 00885556636077
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71175077
• Device Catalogue Number: 71175077
• Device Lot Number: 18GUP0023
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 12/06/2020
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN EVOS PLATING SCREW/UNKNOWN; UNKNOWN EVOS PLATING SCREW; UNKNOWN EVOS PLATING SCREW
• Outcome Attributed to Adverse Event: Required Intervention