MAUDE Adverse Event Report: SYNTHES GMBH 4.5 VACRVD CONDY PL/14H/301/LT; CONDYLAR PLATE FIXATION IMPLANT

Catalog Number 02.124.415

Device Problem Break (1069)

Patient Problem Limb Fracture (4518)

Event Date 04/19/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, there was a revision procedure, where the patient underwent surgery approximately four months ago for a fracture of the femur, where they put a left 14-hole condylar brace plate and cable system, this plate broke and yesterday the plate was removed and a new one is put on.This report is for one (1) 4.5 vacrvd condy pl/14h/301/lt.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: reporter is a j&j employee.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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: d2: additional procodes: hrs, hwc.D4, d10.H3, h4, h6: lot:366p318.Part: 02.124.415.Manufacturing site: mezzovico.Release to warehouse date: 14 september 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Photos of the item were received as well and the findings were consistent with physical device investigation.Visual analysis of the returned sample revealed that 4.5 vacrvd condy pl/14h/301/lt was observed to be broken in two parts.The broken parts were received in the evidence provided.A dimensional inspection for the 4.5 vacrvd condy pl/14h/301/lt was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 4.5 vacrvd condy pl/14h/301/lt would contribute to the complained device issue.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.Drawing/specifications reviewed.The following source controlled drawings reflecting the current and manufactured revisions were reviewed: va lcp curved condylar plate 6-22 holes / left and rigth curved condylar plate.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.D2.D9.

• Brand Name: 4.5 VACRVD CONDY PL/14H/301/LT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14427957
• MDR Text Key: 291935485
• Report Number: 8030965-2022-03252
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454118
• UDI-Public: (01)07611819454118
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415
• Device Lot Number: 366P318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5MM CORTEX SCREW SELF-TAPPING 30MM; 4.5MM CORTEX SCREW SELF-TAPPING 30MM; 5.0 CANNULATED VA LCK SCRW/55; 5.0 CANNULATED VA LCK SCRW/60; 5.0 CANNULATED VA LCK SCRW/70; 5.0 VA LCK SCRW/S/TAP /28; 5.0 VA LCK SCRW/S/TAP /46; 5.0MM CANNULATED VA LOCKING SCREW/65MM; CORTSCR Ø4.5 SELF-TAP L34 SST; CORTSCR Ø4.5 SELF-TAP L40 SST; UNK - CABLE/WIRE: TRAUMA; UNK - CABLE/WIRE: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Sex: Female