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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 POSTLAT DSTL HUM PL 7H/RT/127MM-LONG PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP POSTLAT DSTL HUM PL 7H/RT/127MM-LONG PLATE, FIXATION, BONE Back to Search Results
Model Number 02.117.207
Device Problems Fitting Problem (2183); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
Additional product code: hwc. Complainant device is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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, the variable angle (va) self tapping locking screw went through the va locking compression plate (lcp) posterolateral distal humerus plate. The surgeon was using the va elbow system. The case was going fine until the last screw placement into the plate. The surgeon predrilled with a drill bit on a nominal angle. The surgeon powered the locking screw down, and stopped short of the plate and went to tighten by hand and the screw went directly through plate countersinking into the bone. The screw was not into the joint so the surgeon decided to leave the screw implanted in the bone. No action was done due to it would require taking all of the screws and the plate off and starting over. If the screw migrates into the joint, the patient would have to come back for a revision. It is unknown if there was a surgical delay. Patient and surgical outcome is unknown. Concomitant device reported: drill / drill bit (part# 323. 062 lot# unknown, quantity# 1). This complaint involves one (1) device, 2. 7mm/3. 5mm va-lcp postlat dstl hum pl 7h/rt/127mm-long. This report is 2 of 2 for (b)(4).
 
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Brand Name2.7MM/3.5MM VA-LCP POSTLAT DSTL HUM PL 7H/RT/127MM-LONG
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)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7920627
MDR Text Key122479155
Report Number2939274-2018-53995
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120717
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 09/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.117.207
Device Catalogue Number02.117.207
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2018
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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