MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.416

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that, the medical records received on (b)(6) 2022, the patient underwent an open reduction internal fixation (orif) distal femur fracture due to right periprosthetic distal femur fracture.On (b)(6) 2022 the patient had a revision due to nonunion right distal femur shaft fracture about total knee arthroplasty (tka).This report is for one (1) 4.5mm va-lcp curved condylar plate/16 hole/336mm/right.This is report 1 of 11 for complaint: (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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is lawyer.Device evaluated by mfr, device manufacture date: 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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the va-lcp condylar plate 4.5/5.0 r 16ho l33 is broken in two pieces.Both pieces are shown in the pictures.No other defect was found.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the va-lcp condylar plate 4.5/5.0 r 16ho l33.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.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.D10: concomitant devices added.Date of concomitant therapy is (b)(6)2022.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16731064
• MDR Text Key: 313196890
• Report Number: 8030965-2023-04433
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454125
• UDI-Public: (01)07611819454125
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 4.5MM CORTEX SCREW SELF-TAPPING 34MM; 4.5MM CORTEX SCREW SELF-TAPPING 36MM; 4.5MM CORTEX SCREW SELF-TAPPING 36MM; 5.0 VA LOCKNG SCR SLF-TPNG/SD/30; 5.0 VA LOCKNG SCR SLF-TPNG/SD/36; 5.0 VA LOCKNG SCR SLF-TPNG/SD/65; 5.0 VA LOCKNG SCR SLF-TPNG/SD/85; 5.0 VA LOCKNG SCR SLF-TPNG/SD/90; 5.0MM CANNULATED VA LOCKING SCREW/30MM
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male