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

Model Number	71070710
Medical Device Problem Codes	Material Fragmentation (1261); Device Markings/Labelling Problem (2911); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
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.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 FOR TSF SHT
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781919
• Report Number: 1020279-2021-03813
• Device Sequence Number: 3268572
• Product Code: JDW
• UDI-Device Identifier: 03596010474308
• UDI-Public: 03596010474308
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 71070710
• Device Catalogue Number: 71070710
• Device Lot Number: 19JSM0484
• 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: 10/13/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1