MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NUT {} 10MM {} NYLON INSERT; PIN, FIXATION, THREADED

Catalog Number	103301
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an external fixation procedure, eight (8) nut 10mm {} nylon inserts could not be turned on a bolt without shearing it.Old style off white/yellow insert worked, but the new bright white insert is faulty.The procedure was resumed, using a competitor device (ideal medical).Procedure was delayed for 60 min.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the devices were received for evaluation at the manufacturing site, but a physical product evaluation was not possible.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review made by the quality engineering team revealed that the only change this device has experienced was the removal of the passivation process back in august 2023.This device was manufactured in 2022, and no other modifications in the design have been done before 2022; therefore, no changes could have affected the performance of this device.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed devices.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.These are single use devices, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should the devices or 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: NUT {} 10MM {} NYLON INSERT
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19032464
• Report Number: 1020279-2024-00664
• Device Sequence Number: 17897471
• Product Code: JDW
• UDI-Device Identifier: 03596010032065
• UDI-Public: 03596010032065
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Catalogue Number: 103301
• Device Lot Number: 22JK00051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown