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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 DHP-LAT SUPT 3H/LT/75MM-SHORT PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 3H/LT/75MM-SHORT PLATE, FIXATION, BONE Back to Search Results
Model Number 02.117.103
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  Malfunction  
Manufacturer Narrative

Additional device 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 on (b)(6) 2021, while performing a distal humerus, the surgeon had to re-adjust locking screws multiple times on a variable angle-locking compression plate (va-lcp) posterolateral distal humerus plate while trying to achieve reduction of the small fragments. Ultimately one or two of the 2. 7 variable angle (va) locking screws did not engage in a plate. Surgeon decided to leave these holes empty. He determined that he had likely damaged the holes re-inserting the screws multiple times. Also while reducing, an adjustment nut fell off of the reduction forceps. The procedure was completed successfully with a surgical delay of ten (10) minutes. There was no patient consequence. This report is for one (1) 2. 7mm/3. 5mm va-lcp postlat dhp-lat supt 3h/lt/75mm-short. This is report 1 of 3 for complaint (b)(4).

 
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Brand Name2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 3H/LT/75MM-SHORT
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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12350626
MDR Text Key267657970
Report Number2939274-2021-04788
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.117.103
Device Catalogue Number02.117.103
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 Received08/24/2021
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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