Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA END-CAP F/A2FN CANN EXTENS. 10 TAN GREY; NAIL, FIXATION, BONE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES USA END-CAP F/A2FN CANN EXTENS. 10 TAN GREY; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 04.009.002S
Device Problem Difficult To Position (1467)
Patient Problem Sedation (2368)
Event Date 06/02/2014
Event Type  Injury  
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the surgeon had difficulty mounting the end-cap.Due to the incident, the operation was extended for forty minutes.The surgeon was able to mount the end-cap by using a crown reamer.This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Device has not been explanted.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
END-CAP F/A2FN CANN EXTENS. 10 TAN GREY
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key3899609
MDR Text Key4674635
Report Number2520274-2014-12206
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.009.002S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-