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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM CANNULATED AWL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM CANNULATED AWL Back to Search Results
Model Number 03.010.041
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 09/04/2020
Event Type  Injury  
Manufacturer Narrative
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 on (b)(6) 2020, the patient underwent intramedullary nail, during the procedure, a piece of the cannulated awl broke off in the greater trochanter. Fragments were generated. The fragment was not able to be removed and remained in the patient. There was no surgical delay. The procedure was successfully completed. Patient status is unknown. This report involves one (1) 14. 0mm cannulated awl. This is report 1 of 1 for (b)(4).
 
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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 Key10599447
MDR Text Key208940780
Report Number2939274-2020-04360
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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,Followup
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Manufacturer09/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
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: 09/29/2020 Patient Sequence Number: 1
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