MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST FX STRUT FOR TSF MED; PIN, FIXATION, THREADED

Model Number	71070720
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a correction of a tibia deformity in a patient, after implantation of a tsf external fixation system; there was a varus/rotational/length correction being done, and it was noticed that the fast fx strut for tsf med did not correspond to the prescription.This was noticed when the patient came back into clinic almost close to the consolidation phase.The strut was not locked properly; despite the fact that the strut was locked down, it was able to rotate, move up, down and lengthen or shorten unintentionally.In order to fix this issue, the piece was locked manually using tape in the same device.The deformity correction could have been a lot smoother had this incident not occur.The condition of the patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure.The device appears to have a white substances on it.The device shows significant signs of wear and use.A functional evaluation was conducted on the returned complaint device which is only one year old and exhibits signs of significant wear/usage.Upon functional evaluation, it was confirmed that the part functions as intended and locks as intended.There appears to be a "wax-like" substance on the knobs and locking mechanism.Unclear what substance is.A medical investigation was conducted and confirms based on the information that the fast fx strut for the tsf med did not correspond to the prescription and the results of the product evaluation indicated that the device ¿functions as intended and locks as intended¿ the root cause for the report events are the result of a user vs procedural variance.The impact to the patient is understood that they still had the desired deformity correction, but the treatment process could have been smoother.It¿s not known how this implication of a process which was not ¿smooth¿ affected the patient.A review of complaint history on the listed part revealed no prior complaints for the listed batch number with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Possible probable cause could include but not limited the user error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FAST FX STRUT FOR TSF MED
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781909
• Report Number: 1020279-2021-03808
• Device Sequence Number: 11558244
• Product Code: JDW
• UDI-Device Identifier: 03596010443892
• UDI-Public: 03596010443892
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71070720
• Device Catalogue Number: 71070720
• Device Lot Number: 20DSM0169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention