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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 95 DEG CONDYLAR PLATE 12 HOLES/80MM/204MM APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 95 DEG CONDYLAR PLATE 12 HOLES/80MM/204MM APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT Back to Search Results
Catalog Number 237.26
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - plates: distal femur/ unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. 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, a synthes distal femur plate construct will be removed and a total knee will be revised on (b)(6) 2021. The diagnosis for the surgery is listed as ¿painful right total knee arthroplasty with retained distal femur plate¿. This report is for one (1) unk - plates: distal femur. This is report 1 of 2 for complaint (b)(4).
 
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Brand Name95 DEG CONDYLAR PLATE 12 HOLES/80MM/204MM
Type of DeviceAPPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11890548
MDR Text Key253755389
Report Number2939274-2021-02622
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K914546
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 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number237.26
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 Received09/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/26/2021 Patient Sequence Number: 1
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