• 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) 9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/340MM/RT-STERILE ROD, FIXATION, INTRAMEDULLARY

  • 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) 9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/340MM/RT-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.003.248S
Device Problem Failure to Align (2522)
Patient Problems Sedation (2368); No Code Available (3191)
Event Date 03/06/2016
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight are unknown. Udi number: (b)(4). D6/d7: per the event description, it is unlikely that this device was implanted during the procedure. The complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Investigation could not be completed and no conclusion could be drawn as no device was returned. Device history record review: manufacturing location: (b)(4) - manufacturing date: may 30, 2014 - expiration date: april 30, 2023. No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The sterility documentation was reviewed and determined to be conforming. Device 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
It was reported that a patient underwent a surgical procedure on (b)(6) 2016 in order to treat a midshaft femur fracture resulting from a vehicle accident. During the procedure, the surgeon noted that the aiming arm missed the screw holes proximally. An attempt was made laterally to medial static the screw hole, but the drill bit missed the screw. The screw was removed and an alternate screw (120-degree) was inserted, but the same result was achieved. The surgeon was unable to lock the nail proximally, but was successful in achieving distal locking. The procedure was prolonged by thirty (30) minutes due to the intra-operative alignment issue. This report is 3 of 4 for (b)(4).
 
Manufacturer Narrative
Implant date added as the nail was implanted, but the screws had insertion difficulties due to misalignment. Device was not explanted. Device 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 Name9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/340MM/RT-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES (USA)
1051-1101 synthes ave.
monument CO 80132
Manufacturer (Section G)
SYNTHES (USA)
1051-1101 synthes ave.
monument CO 80132
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5523638
MDR Text Key145298607
Report Number1719045-2016-10250
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK040336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.003.248S
Device Lot Number7608323
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/24/2016 Patient Sequence Number: 1
-
-