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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 OLECRANON PL 4H/LT/116MM PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM PLATE, FIXATION, BONE Back to Search Results
Model Number 02.107.304
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2018
Event Type  Malfunction  
Manufacturer Narrative

Additional product code: hwc. Device has not been reported as explanted. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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 the patient underwent open reduction internal fixation of olecranon and radial head, and olecranon plate implantation on (b)(6) 2018. The 4 hole 2. 7/3. 5 va olecranon plate was implanted and the two locking screws holes were left empty. During the procedure two of the locking holes in the plate did not allow the (2) unknown locking screws to engage and would not lockdown into the plate, and with pressure used to try and insert the screw, the holes began to strip the threads of the screw. It was noted that unknown cortex screw and unknown locking screw were used to attached the plate. There was a five (5) minute surgical delay reported. The procedure was successfully completed. Patient outcome was unknown. Concomitant device reported: cortex screw (part 202. Xxx, lot unknown, quantity unknown); locking screw (part 02. 211. Xxx, lot unknown, quantity unknown) this is report 1 of 3 for (b)(4).

 
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Brand Name2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7603128
MDR Text Key111154241
Report Number2939274-2018-52507
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.107.304
Device Catalogue Number02.107.304
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 Received05/21/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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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