MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERIARTIC AIM ARM 4.5 LCP PROX TIB PL-RT; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.120.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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 or Problem Description
It was reported that, when the curved condylar plate and the aiming arm was attached, it was not able to attach due to the strippage of the screw hole of the plate.While using the aiming arm on the new unknown plate, the neutral sleeves were not connecting to the harpoon.The pediatric aiming arm was outrigger.Procedure was completed successfully with (10) minutes delay.No patient consequence.This report is for (1) periarticular aiming arm for 4.5mm lcp prox tibia pl-rt.This is report 7 of 8 for complaint (b)(4).

• Brand Name: PERIARTIC AIM ARM 4.5 LCP PROX TIB PL-RT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12525825
• Report Number: 2939274-2021-05741
• Device Sequence Number: 17016184
• Product Code: FZX
• UDI-Device Identifier: 10886982073990
• UDI-Public: (01)10886982073990
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.120.001
• Device Catalogue Number: 03.120.001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.3 VA SPHERCL DRL GUIDE LG 5.0 VAL SCRS; 4.5 VA-LCP CRVD COND PL/10 HOLE/230/LFT; INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; NUT INTRLCK BOLT VA LCP COND INSRTN HNDL; TROCAR HANDLE FOR USE 03.120.014
• Outcome Attributed to Adverse Event: Required Intervention