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

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

Patient Problem Tingling (2171)

Event Type  Injury  

Event Description

"tibial lengthening using a reamed type intramedullary nail and an ilizarov external fixator".Author: hayoung kim et al., international orthopaedics (sicot) (2009).This retrospective study was performed on 18 tibiae (13 patients).An smith and nephew ilizarov external fixator was used in all cases of tibial lengthening over an intramedullary nail.It was documented on the paper that one patient complained of paraesthesia of the plantar aspect of the associated foot, but this abnormal sensation was not evident 3 months after surgery.

Manufacturer Narrative

It was reported from a literature review that the patient complained of paraesthesia of the plantar aspect of the associated foot, but this abnormal sensation was not evident 3 months after surgery.This paper was published in 2008.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed at this time.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.The reported event is generally caused by compressed or pinched nerve.The author of this paper stated that this abnormal sensation was not evident 3 months after surgery.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: UNKNOWN ILIZAROV EXFIX DEV
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10047353
• MDR Text Key: 190635657
• Report Number: 1020279-2020-01606
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/15/2020
• Date Manufacturer Received: 08/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other