MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.7MM HEXDRIVER; SCREWDRIVER

Model Number	71173540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during trauma procedure, the 4.7mm hexdriver broke while in use inside the patient.If is unknown how the pieces were retrieved and if there was any surgical delay.It is unknown how the procedure was finished.No patient injury or other complications were reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during trauma procedure, the 4.7mm hexdriver broke while in use inside the patient.The pieces were retrieved a bur and pick ups, and a delay of 15 minutes was reported.The procedure was finished using a smith and nephew back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation; however, an attached photo confirmed that the device was broken.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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: 4.7MM HEXDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11881838
• Report Number: 1020279-2021-04667
• Device Sequence Number: 14240126
• Product Code: HXX
• UDI-Device Identifier: 03596010519672
• UDI-Public: 03596010519672
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71173540
• Device Catalogue Number: 71173540
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 08/04/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/02/2021; 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention