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

Model Number 71692852

Device Problems Failure to Power Up (1476); Application Program Problem (2880)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 206284524
• Report Number: 1020279-2020-04493
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556584644
• UDI-Public: 00885556584644
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1