MAUDE Adverse Event Report: SMITH & NEPHEW, INC. THREADED ROD 400MM; PIN, FIXATION, THREADED

Model Number	102314
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dr.States that 10mm nuts are sticking onto threaded rods, making it unable to thread and unthread up and down the rod.This has happened multiple occasions on 400mm rods, but also on the shorter rods.Happens when adjusting in clinic after procedure.Because of this malfunction, procedure was delayed more than 30 min and an s+n backup device was necessary.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A nut is stuck on the device and cannot be removed.The threads on the device are heavily damaged around the failure site.A review of complaint history did not reveal additional complaints for the listed device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include improper handling or storage.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: THREADED ROD 400MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10261778
• Report Number: 1020279-2020-03105
• Device Sequence Number: 19454244
• Product Code: JDW
• UDI-Device Identifier: 28033201841871
• UDI-Public: 28033201841871
• Combination Product (Y/N): N
• 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): 08/08/2021

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: 102314
• Device Catalogue Number: 102314
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/11/2020
• Supplement Report FDA Received Date: 08/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1