MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED VA LOCKING SCREW/75MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.231.675

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date of event: event year is reported as 2021; however exact date of event is unknown.Additional product code: hrs, hwc.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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 unknown date, patient underwent a removal of hardware from distal femur due to pain.There was no surgical delay noted.The procedure was successfully completed.Patient status is unknown.This complaint involves ten (10) devices.This report is for one (1)5.0mm cannulated va locking screw/75mm.This is report 9 of 10 for (b)(4).

Manufacturer Narrative

Product complaint # : (b)(4).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.H10 additional narrative: d6a, 6b: updated h3, h6: investigation summary: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.

• Brand Name: 5.0MM CANNULATED VA LOCKING SCREW/75MM
• 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
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12779846
• MDR Text Key: 280532547
• Report Number: 2939274-2021-06569
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982062901
• UDI-Public: (01)10886982062901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.231.675
• Device Catalogue Number: 02.231.675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: 4.5 VACRVD CONDY PL/12H/266/LT; 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 5.0 VA LOCKNG SCR SLF-TPNG/SD/32; 5.0 VA LOCKNG SCR SLF-TPNG/SD/32; 5.0 VA LOCKNG SCR SLF-TPNG/SD/34; 5.0MM CANN. VA LCKN SCRW/70MM; 5.0MM CANN. VA LCKN SCRW/75MM; 5.0MM CANNU. VA LCKN SCRW/75MM; 5.0MM CANNULATED VA LOCKING SCREW/70MM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female