MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA INTERFACE - 2ND GENERATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692852
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected data: d1, d4.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during trauma surgery, the trauma interface gave problems on friday in a case.The monitor was reading that the red and green circles were concentric in the middle of the distal screw hole, however when it was tried to drill through said screw hole it was hit the nail despite the monitor showing that the drill was in the right spot.It is unknown how the procedure was completed or if there was any delay.No other complications were reported.
Additional Manufacturer Narrative
B5, d10, h6.
Event or Problem Description
It was reported that during trauma surgery, the trauma interface gave problems on friday in a case.The monitor was reading that the red and green circles were concentric in the middle of the distal screw hole, however when it was tried to drill through said screw hole it was hit the nail despite the monitor showing that the drill was in the right spot.The procedure was completed after a non-significant delay (about 25-30 minutes) making an additional bone hole, because the original hole we drilled was too anterior.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: the devices were received; however, a physical evaluation was not possible as the products were inadvertently misplaced.The photograph was reviewed and revealed that the nail is chipped.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.A damaged sensor, calibration accuracy damage due to wear or an outdated software version are likely potential factors that could contribute to the reported event.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.We consider this investigation closed.

• Brand Name: TRAUMA INTERFACE - 2ND GENERATION
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22025054
• Report Number: 1020279-2025-00868
• Device Sequence Number: 7238082
• Product Code: OLO
• UDI-Device Identifier: 00885556584644
• UDI-Public: 885556584644
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2025

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 Model Number: 71692852
• Device Catalogue Number: 71692802
• Device Lot Number: ACJ1001297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; 09/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/20/2025; 06/12/2025; 09/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71631021 / LOT: 08CBP0001.; PN: 71631024 / LOT: 10CM01129.; PN: 71646130 / LOT: 23FT74921.; PN: 71692805 / LOT: 10DBP0008.; PN: 71692806 / LOT: 10ESP0001.; PN: 71692815 / LOT: 23EK00090.; PN: 71692851 / LOT: ND7256.
• Patient Sex: Unknown