MAUDE Adverse Event Report: SYNTHES SELZACH END-CAP F/A2FN CANN EXTENS. 0 TAN GREY; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.009.000S

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Sedation (2368)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight not available for reporting.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported on (b)(6) 2017 patient underwent a procedure to remove hardware implanted on an unknown date to treat a femoral diaphysis fracture.During the removal procedure, surgeon was not able to remove the end cap.It was decided to break the end cap using a carbide drill.Once completed, the end cap was removed safely using a removing tool.The area was washed thoroughly in order to remove any broken fragments.Intraoperative images verified no fragments were left in the patient.Surgery was completed with a delay of approximately three (3) hours.No adverse consequence to the patient was reported.Surgeon opinion was that the end cap may have been inserted diagonally with force or may have been tightened too much, causing the removal issue.Concomitant devices reported: carbide drill (quantity 1), removing tool (quantity 1).This report is for one (1) end cap for a2fn.This is report 1 of 1 for (b)(4).

• Brand Name: END-CAP F/A2FN CANN EXTENS. 0 TAN GREY
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6948199
• MDR Text Key: 89357225
• Report Number: 3000270450-2017-10362
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2017

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 Catalogue Number: 04.009.000S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR