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

Model Number 5

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2014

Event Type  malfunction  

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 Description

Femoral/tibial fixation- "during dr.(b)(6) 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
• Type of Device: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6382257
• MDR Text Key: 69248829
• Report Number: 2027111-2017-01524
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607915114725
• UDI-Public: (01)00607915114725(17)170807(30)01(10)1207798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 11/07/2018
• Device Model Number: 5
• Device Catalogue Number: 5
• Device Lot Number: 1207798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1