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

Model Number	71692852
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, a trauma interface - 2nd gen displayed an oxc000014c error code.As this was noticed in a non-surgical environment, there was no patient involved.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.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 complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible probable cause could include but not limited to software not programmed correctly, software not updated, connection or mechanical issues.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device does not show any sign of severe damage.A functional evaluation of the returned device could not confirm the stated failure mode.The device functioned as intended and did not display an error message.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.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 do not have 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.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could not be corroborated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, a broken wire in the targeter cable, bent pins in the connector or an open circuit on the data line 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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRAUMA INTERFACE - 2ND GEN
• 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: 12408660
• Report Number: 1020279-2021-06678
• Device Sequence Number: 3349935
• Product Code: OLO
• UDI-Device Identifier: 00885556584644
• UDI-Public: 00885556584644
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2022

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: 71692852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 03/30/2022
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/04/2021; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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