MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA INTERFACE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 71692802

Device Problem Failure to Power Up (1476)

Patient Problem Injury (2348)

Event Date 05/27/2020

Event Type  Injury  

Event Description

It was reported that, during a tibial nail surgery, sureshot monitor (trauma interface) couldn't be turned on and free hands were used to complete the surgery.Current state of health of the patient is good.There are no operative reports available.

Manufacturer Narrative

It was reported that, during a tibial nail surgery, trauma interface couldn't be turned on and free hands were used to complete the surgery.The affected complaint device, used in treatment, was not returned for evaluation.Therefore product analysis could not be performed at this time.However, pictures were provided which could not confirm the stated failure.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No patient injuries or adverse consequences were reported, the patient status was reported as ¿good.¿ since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.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.The device user manual is available, identifying pre-operative requirements for use and suggesting that the targeter should be connected at least 10 minutes prior to targeting.

• Brand Name: TRAUMA INTERFACE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10174574
• MDR Text Key: 195757851
• Report Number: 1020279-2020-02607
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 03596010648174
• UDI-Public: 3596010648174
• Combination Product (y/n): N
• PMA/PMN Number: K170280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71692802
• Device Lot Number: 50506584
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention