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

Catalog Number	71692802
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10174574
• Report Number: 1020279-2020-02607
• Device Sequence Number: 2153536
• Product Code: OLO
• UDI-Device Identifier: 03596010648174
• UDI-Public: 3596010648174
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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 Catalogue Number: 71692802
• Device Lot Number: 50506584
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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