MAUDE Adverse Event Report: DEPUY MITEK UNKNOWN BIO-INTRAFIX; MITEK ACL IMPLANTS

Catalog Number UNK BIOINTRAFIX/INTRAFIX

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

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ investigation summary
=
> the complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.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.Depuy synthes has been informed that the catalog number and lot number is not available.Associated medwatch: 1221934-2018-50120.

Event Description

It was reported via email from mitek npd manager that a surgeon contacted him via email on a patient that had a revision acl over a year ago is having intermittent skin rash at the tibial tunnel.Not infected, dermatologist and allergist agree it's allergic.Lends itself only to some reaction to biointrafix or orthocord which was used for whipstitching.

• Brand Name: UNKNOWN BIO-INTRAFIX
• Type of Device: MITEK ACL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS SARL; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7228331
• MDR Text Key: 98582110
• Report Number: 1221934-2018-50119
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/02/2018

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: UNK BIOINTRAFIX/INTRAFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2018
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/30/2018
• 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