MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP DS W/ORTHOCORD *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222981
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2016
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 has been reviewed.Visual inspection confirms that the distal portion of the anchor is bent.A dhr 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 any incident related to the reported problem, and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed one(1) other similar complaint reported from this lot of devices that were released to distribution.Given that this complaint was reported from a location with high temperature, it is probable that the failure is not related to product design or assembly.Rather, the package may have been exposed to high temperature over a period of time, thus causing the plastic anchor material to soften and deform.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.(b)(4).This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported during a shoulder procedure the lupine hook was found to be bent.The status of the patient and procedure is unknown.This is report 1 of 1 for (b)(4).

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8285957
• Report Number: 1221934-2018-53309
• Device Sequence Number: 2418611
• Product Code: MAI
• UDI-Device Identifier: 10886705008599
• UDI-Public: 10886705008599
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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): 01/16/2017

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: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 222981
• Device Lot Number: 3841320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1