MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FREEDOM POST; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71067382
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one (1) freedom post is broken.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The hex nut and bolt broke off the device, rendering the device inoperative.The broken components were not returned.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.Damage from misuse or rough handling are likely probable causes of the reported event.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.D8 and d9: device returned g2: report source update.

• Brand Name: FREEDOM POST
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12112054
• Report Number: 1020279-2021-05643
• Device Sequence Number: 11706089
• Product Code: KTT
• UDI-Device Identifier: 03596010607928
• UDI-Public: 03596010607928
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 71067382
• Device Catalogue Number: 71067382
• Device Lot Number: 21ATX0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1