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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM RIGHT PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM RIGHT PLATE, FIXATION, BONE Back to Search Results
Model Number 02.211.402
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2020
Event Type  malfunction  
Manufacturer Narrative
Patient identifier mrn: (b)(4). Additional device product codes: 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) 2020, while repairing a calcaneus the surgeon was inserting a locking 2. 7 screw percutaneously through a small incision in the skin. After inserting the screw, the surgeon realized he had missed the va calcaneus plate and buried the screw in the bone. The surgeon elected to not retrieve the screw buried in the bone. In another portion of this case, the surgeon used a variable angle locking hole multiple times and resulted in the screw locking mechanism no longer working. The surgeon ended up removing the screw. There was no surgical delay reported. The procedure was successfully completed. There was no patient consequence. Concomitant devices reported: screwdriver (part number unknown, lot unknown, quantity 1), screws: locking (part number unknown, lot unknown, quantity 2). This report involves 1 2. 7mm va-locking calcaneal plate medium 64mm right. This is report 3 of 3 for (b)(4).
 
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Brand Name2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM RIGHT
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 Key10566033
MDR Text Key207939260
Report Number2939274-2020-04235
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131186
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 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.211.402
Device Catalogue Number02.211.402
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 Received08/27/2020
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

Patient Treatment Data
Date Received: 09/22/2020 Patient Sequence Number: 1
Treatment
UNK - SCREWDRIVERS; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
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