MAUDE Adverse Event Report: DEPUY MITEK LLC US PANALOK RC QUICK ANCHOR PLUS, W/DUAL SUTURE PANACRYL; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212732
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).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.The batch review 3694720 showed that the devices were conformed to in process and finished goods specifications when released to stock the 29 apr.2013.Expiration date: 2016-04 (according to retained labels).No nc was opened.The complaint device was received and evaluated.Visual inspection revealed that only inserter and suture were received.The anchor itself was not received.There was tissue debris on the inserter and the suture.We cannot confirm this complaint or discern a root cause for the reported failure without the anchor.Typically, from historical investigations, anchor breaks are associated with use of incorrect instruments, levering during insertion or axial misalignment.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints 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, depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The procedure was rcr.Anchor broke when surgeon hit it in before any tying of suture.No adverse effect to patient, other than extra anesthetic time.There was five (5) minutes delay in procedure, just to get a new anchor.Broken items all removed and another anchor inserted.

• Brand Name: PANALOK RC QUICK ANCHOR PLUS, W/DUAL SUTURE PANACRYL
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7667424
• Report Number: 1221934-2018-51730
• Device Sequence Number: 11025537
• Product Code: MAI
• UDI-Device Identifier: 10886705002184
• UDI-Public: 10886705002184
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2013

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: 04/01/2016
• Device Catalogue Number: 212732
• Device Lot Number: 3694720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2013
• Initial Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1