MAUDE Adverse Event Report: DEPUY MITEK MINI QA+ W/ #2/0 OCORD AND V-5 NEEDLE W/BIT; MITEK ANCHOR IMPLANTS

Catalog Number 212035

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 05/05/2015

Event Type  Injury  

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Depuy synthes has been informed that the lot number is not available.

Event Description

Patient has allergic reaction due to implanted anchor, the immune system reacts sensitive.Additional information received via email from the affiliate on 11-1-16.The right description is: gii mini quick anchor plus ((b)(4)).What type of procedure did the patient have on (b)(6) 2015? right foot operation: ep arthrodese d1, ehl-ehb transfer, edl-edb transfer 2-5, edlelongation 5, hohmann op 2-4, distale flexortenotomie 2-4.It is unknown when the issue started.The patient¿s symptoms was little redness around the scar.Lot number is unknown.An allergic reaction test has been done, the results oft he tests are not here yet.The anchor is not going to be removed as of now.Current status of the patient is unknown.

Manufacturer Narrative

The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.Patient's current condition is unknown.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.A review of this product code revealed no other similar complaints in the last 3 years.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.

• Brand Name: MINI QA+ W/ #2/0 OCORD AND V-5 NEEDLE W/BIT
• Type of Device: MITEK ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6128162
• MDR Text Key: 60903763
• Report Number: 1221934-2016-10507
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 212035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2016
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other