MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TAYLOR SPATIAL FRAME EXFIX RING; PIN, FIXATION, THREADED

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported that, on the literature review "reducing the risk of ring breakage in taylor spatial frames: the effect of frame configuration on strain at the half-ring junction", four (4) patients experienced the fracture at the half-ring junction of a taylor spatial frame external ring.The identity of the specific components used during treatment, as well as the measures taken to resolve these outcomes where not provided within the study contents.The outcome of these four (4) patients remains unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the devices, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, specific patient and clinical documentation has not been provided.The patients¿ current conditions are unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, fit/size of device, surgical technique or postoperative care.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.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.Internal complaint reference number: (b)(4).

• Brand Name: UNKN TAYLOR SPATIAL FRAME EXFIX RING
• Type of Device: 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: 15307218
• MDR Text Key: 298761997
• Report Number: 1020279-2022-03848
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention