MAUDE Adverse Event Report: DEPUY MITEK 4.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD; MITEK ANCHOR IMPLANTS

Catalog Number 222295

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for a physical evaluation and therefore a root cause for this failure cannot be discerned.Furthermore, no lot numbers were supplied which precludes conducting a batch history 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 (b)(4) 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.

Event Description

The sales rep reported that during a rotator cuff repair that the inserter on the customer's healix advance br 4.5mm anchor broke off flush inside the anchor once it was implanted.The sales rep reported that the inserter was flush in the anchor and that the anchor was fully contained within the bone ant not proud.The sales rep reported that the sutures on the anchor because severed once the inserter broke.The surgeon completed the procedure by implanting an iconic suture anchor just anterior to the original implant to secure the fixation.There were no patient consequences or delays reported.The sales rep reported that the patient was (b)(6) with very hard bone.The sales rep confirmed that the additional anchor was used due to the sutures breaking on the original anchor.

• Brand Name: 4.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD
• Type of Device: MITEK ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: joseph cipollo ; 325 paramount drive; raynham, MA 02767 ; 5089773839
• MDR Report Key: 5414992
• MDR Text Key: 37615672
• Report Number: 1221934-2016-10020
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120078
• 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: 01/08/2016

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: 222295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2016
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 02/06/2016
• 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