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
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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).
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2939274-2019-57453
• Device Sequence Number: 13898321
• Product Code: JDP
• UDI-Device Identifier: 10886982077301
• UDI-Public: (01)10886982077301
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.231.003
• Device Catalogue Number: 03.231.003
• Device Lot Number: L425543
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 04/22/2019; 05/15/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/10/2019; 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1