MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MEDIUM TRANSPORT STRUT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	71935756
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an external fixation, it was found that the patient had tightened the struts excessively, preventing adjustments.A spanner had to be used to attempt to turn one (1) medium transport strut and make adjustments.While using the spanner to turn the strut, the strut cone broke away as a result.The procedure resumed, after a significant delay; however, it is unknown how.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
This complaint has been reassessed based on additional information gathered by the manufacturer.It was determined that this event does not fulfill reporting requirements per 21cfr803.Although a significant delay was previously reported, it has been confirmed that the patient was not sedated (local/general anesthesia) during the follow up visit to conduct the frame adjustments.As such, this event would require the use of a back up strut to continue with treatment without any impact to the patient.Reportedly, this event did not lead to serious injury.

• Brand Name: MEDIUM TRANSPORT STRUT
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 19893481
• Report Number: 1020279-2024-01494
• Device Sequence Number: 7796349
• Product Code: KTT
• UDI-Device Identifier: 00885556725252
• UDI-Public: 885556725252
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K202762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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
• Device Catalogue Number: 71935756
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown