MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIXADV BR 5PK-3SUTURE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 222320

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(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.Udi: (b)(4).The lot number and expiration date are not currently available.

Event Description

It was reported by our sales rep that while surgeon was attempting to use a healix advance br triple loaded anchor with orthocord for a rotator cuff repair.After creating his pilot hole with the mitek awl, he attempted to insert the anchor, and after initial difficulty of getting the anchor inserted, he noticed that the distal tip of the anchor had bent, at which point he deemed it unusable.The surgeon had another healix anchor opened and the case was continued without any further mishaps.There were no patient consequences.

Manufacturer Narrative

Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 4.5 HEALIXADV BR 5PK-3SUTURE
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7495320
• MDR Text Key: 107747907
• Report Number: 1221934-2018-50591
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705021482
• UDI-Public: 10886705021482
• Combination Product (y/n): N
• PMA/PMN Number: K120078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1