MAUDE Adverse Event Report: SYNTHES MEZZOVICO EXPERT A2FN ¿10 R CANN L340 TAN LIGHT GR; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.009.348S

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Sedation (2368)

Event Date 09/07/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient initial & dob not provided by reporter.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been conducted: manufacturing location: (b)(4), manufacturing date: 18.Dec.2012, expiry date: 01.Dec.2022, no anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No material will be sent back for investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that an index surgery was performed on (b)(6) 2014 for the femoral diaphyseal fracture, and an expert tm afn (b)(4) was inserted.The follow-up surgery was performed on (b)(6) 2015 to extract the intramedullary rod.However, the surgeon was unable to unscrew the end cap at all despite various attempts.The extraction of the end cap and the intramedullary rod was eventually aborted, and the surgery was completed with only extracting the locking screws.Due to the event the surgery was delayed for 90 minutes.The surgeon is not planning another surgery to extract the intramedullary rod and the end cap and intending to leave them remained in the patient.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.A date for the device being explanted was reported in error; device reportedly not able to be removed therefore not able to be explanted.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPERT A2FN ¿10 R CANN L340 TAN LIGHT GR
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5095398
• MDR Text Key: 26464863
• Report Number: 1000562954-2015-10185
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: 04.009.348S
• Device Lot Number: 8200400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 85