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

Catalog Number	71692802
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a trauma surgery, the screen of the trauma interface device froze 5 times while performing the distal locking.No drill holes were performed as the screen kept freezing.Troubleshooting was unsuccessful.The procedure was resumed, after a significant delay with a change in the surgical technique.No other complications were reported.
Additional Manufacturer Narrative
Section h10: the associated device was returned and evaluated.The visual inspection did not reveal any defects on the hardware of the device.Software evaluation was performed by a staff product support engineer and this error was not found.It was concluded that the device freezing the customer experienced was due to one of three issues: faulty or damaged targeter, faulty or damaged probe, magnetic metals were present near the device and caused interference.The device was running the outdated 3.0 version of software, while the current released software version is 4.0.A software update would likely correct any software based issues with this device.The clinical/medical investigation concluded that, based on a review of the information provided, there were no clinical factors found which would have caused or contributed to the failure.Per the report, the trauma interface device froze 5 times, however, no drill holes were performed, and it was reported trouble shooting was unsuccessful.According to the report, the surgeon was able to complete the surgery after a significant delay with a change in the surgical technique.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Since there was no harm alleged to this patient due to the significant surgical delay and no other complications were reported, no further clinical/medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history was not performed as this is a unique serial device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include faulty or damaged targeter, faulty or damaged probe, magnetic metals were present near the device and caused interference and/or software maintenance.Based on this investigation, the need for corrective action is not indicated.Should 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.Internal complaint reference number: (b)(4).

• Brand Name: TRAUMA INTERFACE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15785832
• Report Number: 1020279-2022-04743
• Device Sequence Number: 11522802
• Product Code: OLO
• UDI-Device Identifier: 03596010648174
• UDI-Public: 3596010648174
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 11/12/2022
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown