MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES S/M ALEXIS ORTHO PROTECTOR; KGW

Model Number	HR004
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Direct anterior hip- "alexis ortho material was minimally torn throughout the procedure with a shredded effect versus a straight edge tear.Multiple use of the tools, particularly the rasper appeared to contribute to the material being ripped.Multiple metal retractors were being used at the time, however, it appeared the tearing effect was created by continual use of multiple instruments used.Doctor was still happy with performance of alexis ortho in relation to protecting the skin." type of intervention: removal of all material from patient.Patient status: normal.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: S/M ALEXIS ORTHO PROTECTOR
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5965116
• Report Number: 2027111-2016-00641
• Device Sequence Number: 16318032
• Product Code: KGW
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185(17)181022(30)01(10)1258039
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K100120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2017

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: 10/22/2018
• Device Model Number: HR004
• Device Catalogue Number: 101428801
• Device Lot Number: 1258039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2016
• Supplement Report FDA Received Date: 03/30/2017
• Patient Sequence Number: 1