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

Catalog Number 71692802

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  Injury  

Event Description

It was reported that, during meta-tibia nail application with sureshot procedure, sureshot interface was turned on and displayed error: crc check field.No patient injury, no delay, change in surgical technique were used to finish the procedure.

Manufacturer Narrative

H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history for the listed part revealed prior complaints for the listed failure mode but no other complaints with the same serial number as this is a unique serial device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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: TRAUMA INTERFACE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11689784
• MDR Text Key: 246217590
• Report Number: 1020279-2021-03215
• 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: 07/28/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 71692802
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention