MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA090, DIRECT DRIVE LCA 3/BX; FZP

Model Number	CA090
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon inspection, engineering found the jaws to be locked shut, and confirmed the customer's experience that the device was "unusable." the unit was disassembled; engineering found excessive grease inside of the unit which likely caused a high actuation force.This likely lead to the damage seen on the jaws.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.
Event or Problem Description
Procedure performed unknown - "after opening the packaging, device was found unusable.Jaw was blocked." patient status - "na.".

• Brand Name: CA090, DIRECT DRIVE LCA 3/BX
• Common Device Name: FZP
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6423158
• Report Number: 2027111-2017-01623
• Device Sequence Number: 637813
• Product Code: FZP
• UDI-Device Identifier: 00607915117306
• UDI-Public: (01)00607915117306(17)171209(30)01(10)1236402
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/21/2017

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 Expiration Date: 12/09/2017
• Device Model Number: CA090
• Device Catalogue Number: 101416101
• Device Lot Number: 1236402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2015
• Initial Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1621-2016
• Patient Sequence Number: 1