MAUDE Adverse Event Report: SYNTHES GMBH 4.5 VACRVD CONDY PL/14H/301/LT; ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE

Catalog Number 02.124.415

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: product picture was not provided.Based on the information available, it has been determined that no corrective and 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 history lot: part # 02.124.415-us, lot # 3l56563: a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 2 for (b)(4).It was reported by the sales rep in canada that during an unknown surgery on an unknown date, it was observed that the interlocking bolt for 4.5 va-lcp curved condylar plate insertion handle (03.231.005) got a defect at the distal thread.According to the report, this defect caused a cross thread in the va-lcp curved condylar plate (02.124.415) during insertion of the interlocking bolt handle in the plate.The procedure was completed successfully with a delay of five minutes.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This complaint involves two (2) devices.

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.H3, h4, h6: part # 02.124.415-us; lot # 3l56563; manufacturing site: werk mezzovico; release to warehouse date: 19 feb2019.A manufacturing record evaluation was performed for the finished article lot 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.Visual analysis of the returned sample revealed that here was no damage or defects with the thread holes for 4.5 vacrvd condy pl/14h/3 01/lt, some scratches were noted on the surface of the plate; however, the functionality of the device should not be affected.A dimensional inspection for the 4.5 vacrvd condy pl/14h/301/lt was unable to be performed due complex geometry of the device.A functional test was performed with the mating device (bolt condyla) and cannot be connected correctly due to mating device was observed stripped.The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not 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.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.

• Brand Name: 4.5 VACRVD CONDY PL/14H/301/LT
• Type of Device: ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE
• 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: 14470059
• MDR Text Key: 292378050
• Report Number: 8030965-2022-03406
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415
• Device Lot Number: 3L56563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BOLT F/AIMING ARM INSTR F/VA-LCP CONDYLA.