MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST FX STRUT X-SHORT; PIN, FIXATION, THREADED

Model Number 71070705

Device Problems Material Fragmentation (1261); Device Markings/Labelling Problem (2911); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

It was reported that (3) fast fx strut for tsf {} med ((b)(4)), (6) fast fx strut x-short ((b)(4)), (6) fast fx strut for tsf {} sht ((b)(4)) and (1) fast fx strut for tsf {} lng ((b)(4)) are loosing the black coating on the outside making impossible to read the numbers.Some also will not allow the shoulder bolts to thread in.It is unknown whether the event happened and if there was a patient involvement.

Manufacturer Narrative

H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is severely scratched up and missing the coating, making it difficult to read the ruler.This renders the device inoperative.The device shows signs of extensive use.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.Wear potential causes could include but are not limited to friction, joint tightness or lifetime of device.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: FAST FX STRUT X-SHORT
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781896
• MDR Text Key: 249267624
• Report Number: 1020279-2021-03801
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 03596010479884
• UDI-Public: 03596010479884
• Combination Product (y/n): N
• PMA/PMN Number: K994143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71070705
• Device Catalogue Number: 71070705
• Device Lot Number: 20DSM0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Date Manufacturer Received: 10/21/2021
• Patient Sequence Number: 1