MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ #2/O OCORD V-5; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 212035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4)-incomplete.The lot number is not currently available.

Event Description

It was reported by the patient via email that the patient who had an injury of the middle finger pip joint with surgery of insertion of a mitek anchor model product code 212035: depuy mitek mini quickanchor plus (2/0 suture).The patient stated that during the nearly 1 year recovery, because of the surgery doctor quality.The mitek anchor is making the patient have an uncomfortable feeling with a bit of swelling of the joint.After his consultancy with the good doctor in which is healing him in a better way.The patient stated that he would like to explore any possibilities for the removal of the inserted mitek anchor as his finger tissue is recovered already.

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Upon further investigation, it was determined that the alleged malfunction could not cause or contribute to a death or serious injury.H11: corrected data: b1, h1: the original complaint was reviewed and determined to be not reportable due to our reportability matrix.

• Brand Name: MINI QA+ #2/O OCORD V-5
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7874542
• MDR Text Key: 120201296
• Report Number: 1221934-2018-54637
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001835
• UDI-Public: 10886705001835
• Combination Product (y/n): N
• PMA/PMN Number: K071257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other