• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.013.000
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
It was reported that on an unknown date, the patient underwent a procedure to treat a distal femur fracture with synthes retrograde nail as fixation. During surgery the end cap for a retrograde nail fell off the insertion t40 star drive screwdriver handle. The surgeon failed to get the item out of the patients canal and therefore left the item in the patient. The procedure was completed successfully with a ten (10) minute surgical delay. Concomitant device reported: unk - nails: rafn (part# unknown; lot# unknown; quantity: 1). Unk - screwdriver: handle (part# unknown; lot# unknown; quantity: 1). This report is for one (1) ti end cap t40 strdrv 0mm ext retro femoral nail-ex sprl bld. This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12640144
MDR Text Key276661698
Report Number2939274-2021-06127
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033618
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.013.000
Device Catalogue Number04.013.000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/15/2021 Patient Sequence Number: 1
Treatment
UNK - NAILS: RAFN; UNK - SCREWDRIVERS
-
-