MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; PLATE, FIXATION, BONE

Model Number	02.124.413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-codes: jdp, hwc.Complainant device is not expected to be returned for manufacturer review/ investigation.Initial reporter is j&j company representative.Without a lot number the device history records review could not be completed.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 or Problem Description
It was reported that on (b)(6) 2021, patient underwent a hardware removal and revision surgery due to non-union and implant failure.Patient sustained an open distal femur fracture and was treated with a 4.5mm variable angle (va) locking compression plate (lcp) condylar plate on (b)(6) 2019.The fracture went on to non-union and the plate subsequently broke at the non-union site.The patient was brought to the operating room (or) on (b)(6) 2021 for hardware removal (all hardware was removed uneventfully) and insertion of retrograde femoral nail.It is unknown how the procedure was completed.Patient outcome is unknown.The complaint (b)(4) will capture the excess impacted product with the corresponding part # 02.231.275 of complaint (b)(4) due to limitation of 10 ip's per complaint.Concomitant devices reported: 4.5mm va-lcp curved condylar plate/12 hole/266mm/left, 5.0mm variable angle lockng screw/slf-tpng/strdrv/36mm, 5.0mm variable angle lockng screw/slf-tpng/strdrv/38mm, 5.0mm variable angle lockng screw/slf-tpng/strdrv/70mm, 5.0mm variable angle lockng screw/slf-tpng/strdrv/75mm, 5.0mm variable angle lockng screw/slf-tpng/strdrv/34mm, 4.5mm cortex screw self-tapping 34mm.This complaint involves one (1) device.This report is for one (1) 4.5mm va-lcp curved condylar plate/12 hole/266mm/left.This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11386460
• Report Number: 2939274-2021-01064
• Device Sequence Number: 4037579
• Product Code: HRS
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873
• Combination Product (Y/N): N
• Initial Reporter State: OR
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.124.413
• Device Catalogue Number: 02.124.413
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5MM CORTEX SCREW SELF-TAPPING 34MM; 4.5MM VA-LCP CRVD CONDYLAR PLT/12 HOLE/266MM/LEFT; 5.0MM VARIABLE AGL LOKNG SCW/SLF-TPNG/STRDRV/34MM; 5.0MM VARIABLE AGL LOKNG SCW/SLF-TPNG/STRDRV/36MM; 5.0MM VARIABLE AGL LOKNG SCW/SLF-TPNG/STRDRV/38MM; 5.0MM VARIABLE AGL LOKNG SCW/SLF-TPNG/STRDRV/70MM; 5.0MM VARIABLE AGL LOKNG SCW/SLF-TPNG/STRDRV/75MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR