MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 4.5 VA-LCP CRVD COND PL/12HOLE/266/LT-S; PLATE, FIXATION, BONE

Model Number	02.124.413S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Swelling/ Edema (4577)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is an attorney.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Photo investigation: the device was not returned.A photo-investigation was performed on all the images located under pc attachment received at 14-may-2021.Upon inspecting all the photos provided, the 4.5 va-lcp crvd cond pl/12hole/266/lt-s was found to be fractured/cracked on side of one of the variable angle combination hole near to proximal side of plate.The root cause of the complaint condition cannot be confirmed based on the available images.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot - a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.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) 2018, patient underwent an open reduction internal fixation of left supracondylar femur with intra -articular extension for a left supracondylar femur fracture nonunion with hardware failure due to swelling, plate breakage and nonunion.Concomitant device reported: 4.5mm cortex screw self-tapping 36mm (part # 214.836 lot # unknown, quantity# 1), 5.0mm variable angle lockng screw/slf-tpng/strdrv/36mm (part # 02.231.236 , lot # unknown, quantity# 1), 5.0mm variable angle lockng screw/slf-tpng/strdrv/34mm (part # 02.231.234 lot # unknown, quantity# 2), 5.0mm variable angle lockng screw/slf-tpng/strdrv/36mm (part # 02.231.236 , lot # unknown, quantity# 6), 4.5mm cortex screw self-tapping 80mm (part # 214.880 , lot # unknown, quantity# 6).This report is for one (1) 4.5mm va-lcp curved condylar plate/12hole/266mm/lt-ster.This is report 1 of 1 for complaint (b)(4).
Additional 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.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.H11: corrected data.

• Brand Name: 4.5 VA-LCP CRVD COND PL/12HOLE/266/LT-S
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer (Section G): DEPUY MOTION SARL; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11952433
• Report Number: 3006356043-2021-00001
• Device Sequence Number: 17147601
• Product Code: HRS
• UDI-Device Identifier: 10886982042880
• UDI-Public: (01)10886982042880
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K083025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 02.124.413S
• Device Catalogue Number: 02.124.413S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5MM CORTEX SCREW SELF-TAPPING 80MM.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/34.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/36.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/36.; VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 76 KG