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

Model Number	71692852
Medical Device Problem Codes	Failure to Calibrate (2440); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during humeral internal fixation surgery, the trauma interface - 2nd gen - sureshot was not calibrating properly on humeral nail.Due to this event, a surgical delay greater than 30 minutes was reported and it is unknown how was the procedure concluded.No patient injury was reported.When the device was brought back to office and calibration tests were run, the device sparked from the back.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4) section h1 was corrected according to the new information received.
Event or Problem Description
It was reported that, during humeral internal fixation surgery, the trauma interface - 2nd gen - sureshot was not calibrating properly on humeral nail.Due to this event, a surgical delay greater than 30 minutes was reported and an alternative surgical technique known as perfect circles was applied to conclude the procedure.No patient injury was reported.When the device was brought back to office and calibration tests were run, the device sparked from the back.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.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.G2: report source update.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.There were no signs of spark or electrical damage.A functional evaluation of the returned device could not confirm the stated failure mode.The device functioned as intended.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed 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, misuse or rough handling are 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: 11842487
• Report Number: 1020279-2021-04389
• Device Sequence Number: 17128048
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2022

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 Model Number: 71692852
• Device Catalogue Number: 71692852
• Device Lot Number: 8855556584644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 08/13/2021; 03/22/2022
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/10/2021; 08/17/2021; 03/24/2022
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown