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

Catalog Number	71692852
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, while performing the distal blocks using a trauma interface - 2nd generation, the sureshot failed to provide the corresponding measurement and collided with the nail.The surgeon completed the procedure manually after a non-significant delay.No injuries were reported as a consequence of this issue.
Additional Manufacturer Narrative
H6: the device was not returned for evaluation; therefore, a device analysis could not be performed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed 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 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instrument that can be exposed to numerous surgeries.A damaged sensor, calibration accuracy damage due to wear or an outdated software version are likely potential factors that could contribute to the reported event based on this investigation, the need for corrective action is not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 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 - 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18969655
• Report Number: 1020279-2024-00604
• Device Sequence Number: 6299704
• Product Code: OLO
• UDI-Device Identifier: 00885556584644
• UDI-Public: 00885556584644
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K170977
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 71692852
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71692851 / SN: UNKNOWN
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 60 KG