MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ILIZAROV EXFIX DEV; PIN, FIXATION, THREADED

Catalog Number UNKN02300400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

It was reported that on literature review "limb salvage for osteosarcoma of the distal tibia with resection arthrodesis, autogenous fibular graft and ilizarov external fixator", 1 patient while using a ilizarov external fixation device, resection arthrodesis and autogenous fibular graft for a limb salvage for non-metastatic osteosarcoma of the distal tibia sustained a stress fracture at the proximal end of the non-vascularised fibular graft six months post-operatively.Patient was treated by application of autogenous iliac cancellous graft at the site of the fracture.Full union of the graft occurred after 20 months.No further information is available.

Manufacturer Narrative

Internal reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Shalaby s, shalaby h, bassiony a.Limb salvage for osteosarcoma of the distal tibia with resection arthrodesis, autogenous fibular graft and ilizarov external fixator.J bone joint surg br.2006 dec;88(12):1642-6.Doi: 10.1302/0301-620x.88b12.17879.Pmid: 17159179.

• Brand Name: UNKN ILIZAROV EXFIX DEV
• 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: 17817516
• MDR Text Key: 324253650
• Report Number: 1020279-2023-01847
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKN02300400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2023
• 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