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

Model Number	71692852
Medical Device Problem Codes	Failure to Power Up (1476); Application Program Problem (2880)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trauma interface won't turn on.It is unknown whether the incident happened or not in a surgical environment or if there was any patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Section: h3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.There are not any signs of physical damage to the device.A functional evaluation of the returned device could not confirm the stated failure mode.The device functioned as intended.The device would turn on as well as function along with the mating components.A review of complaint history did not reveal additional complaints for the listed batch.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.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.H6: health effect and medical device problem code.

• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10511791
• Report Number: 1020279-2020-04493
• Device Sequence Number: 3134688
• Product Code: OLO
• UDI-Device Identifier: 00885556584644
• UDI-Public: 00885556584644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/15/2021
• 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