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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA; ROD, FIXATION, INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown nails: tfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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 sales consultant was performing a demo for the surgeon when it was noticed that the drill bit was hitting the nail on the distal locking screw on a short tfna.There was no patient involvement.Concomitant devices reported: unknown locking screws (part# unknown, lot# unknown, quantity# 1).This report is for 1 unk - nails: tfna.This is report 3 of 4 for (b)(4).
 
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Brand Name
UNK - NAILS: TFNA
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10225484
MDR Text Key197383533
Report Number2939274-2020-03072
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
130 DEG AIMING ARM; COMPLETE RADIOLUCENT INSERTION HANDLE; UNK - DRILL BITS: TRAUMA; UNK - SCREWS: LOCKING
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