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	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procodes: hwc, hrs.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.A device history record review has been requested.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 an open reduction and internal fixation (orif) of the right femur on (b)(6) 2018, the arm sleeves of left and right aiming arm were no longer locking securely in the guide.The grooves in the carbon fiber of the aiming arms seem to be wearing out, preventing the metal wings in the sleeves from engaging.The trocar with handle was not properly locking into the sleeves during the sleeve insertion to aiming arm.The case was completed successfully by manually holding the sleeves in the aiming arm during the procedure.There was no surgical delay.There was no patient harm.Concomitant devices: guide (part: unknown, lot: unknown, quantity: 1).This report is for a aiming arm for 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate/left.This is report 1 of 3 for (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: a device history record (dhr) review was conducted: part: 03.231.003, lot: 7549772, manufacturing site: synthes haegendorf, release to warehouse date: 06.May 2011.The device history record shows this lot of 8 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: a product investigation was conducted.Visual inspection: visual inspection of the returned left aiming arm assembly for va-lcp curved condylar plates revealed no damage to any carbon fiber feature of the device.The connection bolt component was not returned.No damage was noted to the mounting sleeve component¿s threads.Slight damage to the top surface of the mounting sleeve was noted.This damage is consistent with use of the device.No damage was noted the pin or any other feature of the device.The damage noted above would have impacted the ability to assemble with the insertion handle.Functional testing: functional testing could not be performed as the insertion handle was not returned.The received condition did not agree with the complaint description.The complaint could not be replicated during investigation.Dimensional inspection: dimensional inspection of the mounting sleeve¿s hole measured 14.00mm.Measured with ca802.This is within specification of 14.00mm +0.05/-0 per se_370849 rev b.Document/specification review: the relevant drawings were reviewed during investigation: no design issues were noted during investigation.Conclusion: the complaint was not confirmed during investigation.No damage was noted any of the features that interact with the insertion handle, which would have contributed to the complaint condition.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: 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: 8199724
• Report Number: 2939274-2018-55604
• Device Sequence Number: 1557622
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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: 7549772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1