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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT IMPLANT,FIXATION DEVICE, CONDYLAR PLATE Back to Search Results
Model Number 02.124.410
Device Problem Break
Event Type  Injury  
Manufacturer Narrative

Additional classification code: hrs and hwc exact implant date is unknown. It occurred in (b)(6) 2017. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). A review of the device history records has been requested. 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 a patient was treated for an orif (open reduction internal fixation) of a distal femur. On an unknown date, the plate was found to be broken, and it was discovered that the patient had developed a non-union, which reportedly led to the removing of the broken hardware. On (b)(6) 2017, the patient returned to the operating to remove broken plate, four (4) intact proximal screws and five (5) intact distal screws. The patient was revised to another plate and screw fixation with bone graft. There was no reported surgical delay, no fragments left in the patient, no additional medical or surgical intervention. The procedure was successfully complete, and the patient was stable during and following the surgery. Concomitant devices: unknown 4. 5 cortex screw ss (part # unknown, lot # unknown, qty. 1); unknown 5. 0 variable angle locking screws ss (part # unknown, lot # unknown, qty. 8). This is report 1 of 1 for (b)(4).

 
Manufacturer Narrative

Device history records review was completed for part# 02. 124. 410, lot# l377249. Manufacturing location: (b)(4), release to warehouse date: apr 20, 2017. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. It is unknown if the device was reprocessed and reused on patient. Therapy date is unknown date in (b)(6) 2017. 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.

 
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Brand Name4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT
Type of DeviceIMPLANT,FIXATION DEVICE, CONDYLAR PLATE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ  6805
Manufacturer Contact
michael cote
west chester , PA 19380
6107195000
MDR Report Key7077160
Report Number8030965-2017-50245
Device Sequence Number1
Product CodeJDP
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.124.410
Device Catalogue Number02.124.410
Device LOT NumberL377249
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 Received04/13/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/20/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/01/2017 Patient Sequence Number: 1
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