• 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 14.0MM CANNULATED AWL

  • 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 14.0MM CANNULATED AWL Back to Search Results
Model Number 03.010.041
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 during an intramedullary (im) nailing of the femur for rotational osteotomy of the femur on (b)(6) 2020, while getting the starting point in the femur for im nail, the tip of the cannulated awl broke off. It took about 30-40 minutes to retrieved the broken piece out of the patient as the surgeon had to make a larger incision in order to access the piriformis fossa where the fragment was lodge. The procedure was successfully completed with the use of an opening reamer. Patient status was unknown. Concomitant device reported: unknown guidewire (part # unknown, lot # unknown, quantity 1). This report is for one (1) 14. 0mm cannulated awl. This is report 1 of 1 for complaint (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name14.0MM CANNULATED AWL
Type of DeviceAWL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9799810
MDR Text Key188860183
Report Number2939274-2020-01164
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
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 02/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number03.010.041
Device Catalogue Number03.010.041
Device LOT Number1493547
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/21/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/06/2020 Patient Sequence Number: 1
-
-