MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 03.231.003

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: hrs, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is synthes sales consultant.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.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 Description

It was reported that during on an unknown procedure on an unknown date, the aiming arm instrument and plate did not align accurately.The insertion handle, interlocking bolt, and six (6) locking neutral guide were used to help stabilize a plate and aiming arm to allow the surgeon to do the procedure percutaneously.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This report is for one (1) aiming arm for 4.5mm va-lcp curved condylar plate.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: device history records review was completed for part: 03.231.003, lot: l425543.Manufacturing location: haegendorf, release to warehouse date: jul 13, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.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 Description

It was reported that on mar 21, 2019 during an unknown procedure, the aiming arm instrument and plate did not align accurately.The insertion handle, interlocking bolt, and six (6) locking neutral guide were used to help stabilize a plate and aiming arm to allow the surgeon to do the procedure percutaneously.The plate was implanted.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This report is for one (1) aiming arm for 4.5mm va-lcp curved condylar plate.This is report 1 of 2 for complaint (b)(4).

• Brand Name: AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/LEFT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8511667
• MDR Text Key: 142213761
• Report Number: 2939274-2019-57453
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982077301
• UDI-Public: (01)10886982077301
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.231.003
• Device Catalogue Number: 03.231.003
• Device Lot Number: L425543
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1