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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED VA LOCKING SCREW/SLF-TPNG/95MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED VA LOCKING SCREW/SLF-TPNG/95MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE Back to Search Results
Catalog Number 02.231.695
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4).Unknown event year and date.Additional product code : hrs 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 as no product was received.The investigation could not be completed and no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 the patient underwent revision due to malunion of distal femur.There was no surgical delay reported.There were fragments generated and it is unknown if they remove easily without additional intervention.The procedure was successfully completed.The patient outcome was unknown.This complaint involves ten (10) devices.This report is for (1) 5.0mm cannulated va locking screw/slf-tpng/95mm.This report is 9 of 10 (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: a device history record (dhr) review was conducted: part # 02.231.695s-us, lot # 57p5790, manufacturing site: mezzovico , release to warehouse date: 22 jun 2020, expiry date: 01 may 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 Name
5.0MM CANNULATED VA LOCKING SCREW/SLF-TPNG/95MM
Type of Device
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key11529241
MDR Text Key241442385
Report Number2939274-2021-01442
Device Sequence Number1
Product Code JDP
UDI-Device Identifier10886982062949
UDI-Public(01)10886982062949
Combination Product (y/n)N
PMA/PMN Number
K110354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number02.231.695
Device Lot Number57P5790
Was Device Available for Evaluation? No
Date Manufacturer Received04/05/2021
Patient Sequence Number1
Treatment
4.5MM VA-LCP CRVD CNDLR PLT/18 HLE/370MM/LFT; 5.0MM CANND VA LKNG SCRW/85MM; 5.0MM CANND VA LKNG SCRW/90MM; 5.0MM CANND VA LKNG SCRW/95MM; 5.0MM CANND VA LKNG SCRW/95MM; 5.0MM VBLE ANGL LKNG SCRW/SLF-TPG/STDR/38MM; 5.0MM VBLE ANGL LKNG SCRW/SLF-TPG/STDR/40MM; 5.0MM VBLE ANGL LKNG SCRW/SLF-TPG/STDR/42MM; 5.0MM VBLE ANGL LKNG SCRW/SLF-TPG/STDR/46MM
Patient Outcome(s) Required Intervention;
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