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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PL 7H/LT/147MM - XLNG PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PL 7H/LT/147MM - XLNG PLATE, FIXATION, BONE Back to Search Results
Model Number 02.117.907
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
Additional product code: hwc. Complainant part is not expected to be returned for manufacturer review/ investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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. 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 a distal humerus fracture procedure on (b)(6) 2020, two (2) 2. 7 variable angle locking screws did not lock into the lateral distal humerus plate. The procedure was successfully completed with the use of 2. 7 metaphyseal screws. There was no surgical delay reported. Patient status was good. This report is for a lateral distal humerus plate. This is report 2 of 3 for (b)(4).
 
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Brand Name2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PL 7H/LT/147MM - XLNG
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10824446
MDR Text Key216123835
Report Number2939274-2020-05128
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.117.907
Device Catalogue Number02.117.907
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 Received10/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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