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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.033.003
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a j&j employee. 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 an unknown date, when the consultant was preparing the set for sterilization it was noticed both of the plastic tabs on the side of the radiolucent aiming arm/frn greater trochanter were broken off. It is unsure where or when the damage took place. There was no patient involvement. This report is for one (1) radiolucent aiming arm/frn greater trochanter. This is report 1 of 1 for (b)(4).
 
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Brand NameRADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER
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)
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 Key10347422
MDR Text Key201427141
Report Number2939274-2020-03330
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.033.003
Device Catalogue Number03.033.003
Device Lot NumberL963559
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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