MAUDE Adverse Event Report: DEPUY MITEK LLC US PANALOK RC QA+DUAL#2ETHG/W MO7; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and evaluated.Visual observation confirms the distal tip of the anchor is broken, but is held in place by suture.The anchor appears to be used and there are evidence of tissue debris found on the anchor and the tip of the shaft.The inserter was examined and no anomalies that would have contributed in the reported failure were found.This type of anchor breakage at its distal tip is consistent with historical investigations in which it was determined that the root cause was likely a combination of torque and bending, or an excessive suture tensioning, a user technique issue.Other than those possibilities, we cannot discern a root cause for this failure.Further, a review into the mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported that during rotator cuff repair the tip of the device broke when the surgeon tried to insert it into a bone hole without excessive force.It was also reported that no broken piece was left in the patient¿s body.By using a replacement, the surgery was completed without any delay.There was no harm to the patient.

• Brand Name: PANALOK RC QA+DUAL#2ETHG/W MO7
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7867402
• Report Number: 1221934-2018-53767
• Device Sequence Number: 16662987
• Product Code: MAI
• UDI-Device Identifier: 10886705001965
• UDI-Public: 10886705001965
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2015

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: 12/31/2016
• Device Catalogue Number: 212132
• Device Lot Number: 3738096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2015
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1