MAUDE Adverse Event Report: SYNTHES GMBH LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM; CONDYLAR PLATE FIXATION IMPLANT

Model Number 03.231.007

Device Problem Device-Device Incompatibility (2919)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, the locking/neutral guide for the 4.5mm va lcp curved condylar plate was malfunctioning and would not lock into place.The procedure was completed successfully with no surgical delay.No patient consequences were reported.No further information is available.This report is for a lock/neutral guide f/4.5mm va lcp crvd condylar aiming arm.This is report 8 of 10 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional procode: hwc, hrs.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: d4: lot number added.D4: expiration date added.Part: 03.231.007.Lot: l425629.Release to warehouse date: 05 oct 2017.Manufacturing site: werk hägendorf.Expiration date: n/a.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 the lck/neut gd 4.5 va lcp crvd cond aim arm, exhibits signs of normal use.No significant product problem was observed on the surface of the device.A dimensional inspection was performed for the lck/neut gd 4.5 va lcp crvd cond aim arm and met specifications.A functional test to assess the reported assembly allegation, was not conducted since the plate was not returned for evaluation.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 lck/neut gd 4.5 va lcp crvd cond aim arm was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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: rev f current, e manufactured dimensional inspection: drawing: e manufactured, feature: shaft diameter, specification: measured dimension: result: conforming, measurement device: caliper mitutoyo cd.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.D9.

• Brand Name: LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15914314
• MDR Text Key: 307889790
• Report Number: 8030965-2022-10623
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982077349
• UDI-Public: (01)10886982077349
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.231.007
• Device Catalogue Number: 03.231.007
• Device Lot Number: L425629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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: LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM
• Patient Sex: Male
• Patient Weight: 136 KG