MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES SOFT/FIBRA INSERT 30MM 10 PER BOX; DXC

Model Number	2
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.The root cause could not be determined.Test results does not indicate that the bonding between the pad and the base has been compromised on the 42 total samples.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.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 with 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
Femoral/tibial fixation- "during dr.(b)(6)'s fem/tib procedure this morning, they opened the insert and noticed that the rubber portion of the insert was coming off.They opened 7-8 of the same lot number and they were all the same.We have pulled the entire lot off of our shelves." patient status: unknown.

• Brand Name: SOFT/FIBRA INSERT 30MM 10 PER BOX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6382253
• Report Number: 2027111-2017-01498
• Device Sequence Number: 18977189
• Product Code: DXC
• UDI-Device Identifier: 00607915114725
• UDI-Public: (01)00607915114725(17)170807(30)01(10)1207798
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 2
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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: 11/07/2018
• Device Model Number: 2
• Device Catalogue Number: 2
• Device Lot Number: 1207798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2014
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1