MAUDE Adverse Event Report: DEPUY MITEK SUPER QUICKANCHOR+ DS W/#2 ORTHOCORD; MITEK ANCHOR IMPLANTS

Catalog Number 222984

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 04/21/2017

Event Type  Injury  

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.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.(b)(4).Depuy synthes has been informed that the lot number is not available.Associated medwatch: 1221934-2017-10301, 1221934-2017-10302, 1221934-2017-10304.

Event Description

The sales rep reported via phone that the patient developed redness and swelling after a gii anchor with orthocord and three super quick anchors plus ds were implanted during and acl procedure.The sales rep stated that the implants went in great but the patient was re-opened to close the wound correctly by the resident as the original closure was done by students.The sales rep was not present for the case and could not provide any more details.The devices are not available to be returned as they are still in the patient.

• Brand Name: SUPER QUICKANCHOR+ DS W/#2 ORTHOCORD
• 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: 6649104
• MDR Text Key: 77825280
• Report Number: 1221934-2017-10303
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2017,05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 222984
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2017
• Date Manufacturer Received: 05/17/2017
• 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