• 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 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 240MM/LT-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
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 240MM/LT-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.008.078S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. (b)(4). Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and 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 history lot: manufacturing location: (b)(4), manufacturing date: 12-mar-2014, part number: 04. 008. 078, 10mm ti hindfoot arthrodesis cann nail ¿ ex 240mm/ left, lot number: 7630108 (non-sterile), lot quantity: (b)(4). Note: this lot number was produced as a non-sterile item. Work order traveler met all inspection acceptance criteria. Inspection sheet, in-process acceptance sheet, op038354 rev a met all inspection acceptance criteria. Inspection sheet, ns037189 rev c met all inspection acceptance criteria. Inspection sheet, final inspection, 04fi008010 rev d met all inspection acceptance criteria. Packaging label log lppf, lmd/lpf rev ab was reviewed and determined to be conforming. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Device history review: 14-nov-2019: dhr reviewed by: (b)(4). This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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 (b)(6) 2019, the patient underwent a revision surgery due to chronic osteomyelitis, infection, inflammation, nonunion of joint, and delayed healing. One (1) hindfoot nail, one (1) spiral blade, one (1) 6mm unknown locking screw, and one (1) 5mm unknown locking screw were removed. All hardware was intact. After the removal, the extremity of the patient was i&d using ria. There was no surgical delay.   it is unknown if procedure was successfully completed. Patient status was good. This complaint involves four (4) devices. This is 1 of 4 for report (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 240MM/LT-STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9342513
MDR Text Key185044394
Report Number2939274-2019-62275
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051678
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 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.008.078S
Device Catalogue Number04.008.078S
Device Lot Number7630108
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 Received11/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2014
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: 11/19/2019 Patient Sequence Number: 1
-
-