MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES HR004, S/M ALEXIS ORTHO PROT 5/BX; KGW

Model Number	14
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned for evaluation.Engineering was able to confirm the customer's experience of a torn sheath.Upon observation, engineering noted a clean cut with no stress marks and edges protruding outward.A review of the manufacturing records for the lot number provided reveal that the product passed all quality and manufacturing inspections.The root cause of the tear is most likely the exchange of tools.Some sharp instrument is required to make a tear similar to the one observed.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Procedure performed unknown - "the alexis tore during the procedure during the hip replacement while using basic ortho instrumentation.This was a trial product, no replacement or credit needed." patient status - okay.

• Brand Name: HR004, S/M ALEXIS ORTHO PROT 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6378872
• Report Number: 2027111-2017-01389
• Device Sequence Number: 552615
• Product Code: KGW
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185(17)180818(30)01(10)1253394
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 14
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/03/2017

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: Other
• Device Expiration Date: 08/18/2018
• Device Model Number: 14
• Device Catalogue Number: 14
• Device Lot Number: 1253394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Distributor Facility Aware Date: 11/10/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2015
• Initial Report FDA Received Date: 03/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 'BASIC ORTHO REPLACEMENT INSTRUMENTATION.'