MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMART TSF WIRE COMBI BOLT; WASHER, BOLT, NUT, NON-SPINAL, METALLIC

Catalog Number	71075284
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during external fixation surgery, three (3) smart tsf wire combi bolts sheared and broke at the nut.The procedure was resumed, without after a delay greater than 30 minutes using a s+n back up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4) the devices were not returned for evaluation.However, the photographs were reviewed and revealed that the reported devices are fractured.Device batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed. a review of complaint history of the previous 12 months revealed similar events for the listed devices, this failure mode will be monitored for future complaints for any necessary corrective actions.  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 these products 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: SMART TSF WIRE COMBI BOLT
• Common Device Name: WASHER, BOLT, NUT, NON-SPINAL, METALLIC
• 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: 21375078
• Report Number: 1020279-2025-00273
• Device Sequence Number: 8623634
• Product Code: NDG
• UDI-Device Identifier: 00885556746028
• UDI-Public: 885556746028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: 71075284
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown