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

Catalog Number	71692802
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, after turning on the trauma interface, it did not display the main menu; it displayed windows screen.Several attempts of turning off/on the system, the issue was not resolved.Using a radiolucent drill, the operation was completed.4 min surgical delay.Patient was not harmed.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So 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.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• 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: 11144565
• Report Number: 1020279-2021-00232
• Device Sequence Number: 3607079
• Product Code: OLO
• UDI-Device Identifier: 03596010648174
• UDI-Public: 3596010648174
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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 Catalogue Number: 71692802
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 01/10/2021
• Supplement Report FDA Received Date: 05/31/2021
• 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: Required Intervention
• Patient Weight: 80