MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE BR W/OC&ND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222299
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	02/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The exp date is currently unavailable.The complaint device was received and evaluated.Visual inspection revealed blood residue on the anchor and suture.The distal tip of the anchor was completely broken off, confirming this complaint.The broken fragment was pulled away from the main body of the anchor but remained connected via the sutures.The anchor break was circumferential and flush with the distal end of the inserter.Visual examination revealed the threads on the distal half of the anchor were distressed, indicating that the anchor was partially inserted.It was reported that the patient had hard bone quality, which likely contributed to or caused the observed anchor break.Other typical causes of anchor breakages which may have contributed to this event include off axis insertion and levering during insertion.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution.At this 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 to monitor the extent to which this complaint is observed in the field.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the 5.5 healix advance br w/oc&nd anchor device broke off during placement.It was reported that the device could be completely removed and the procedure was completed with a new anchor using the same bone hole.It was not reported if there was a delay in the surgical procedure.It was reported that the patient had hard bone quality.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Anchor.

• Brand Name: 5.5 HEALIX ADVANCE BR W/OC&ND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8258479
• Report Number: 1221934-2018-51732
• Device Sequence Number: 19359234
• Product Code: MAI
• UDI-Device Identifier: 10886705021352
• UDI-Public: 10886705021352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 222299
• Device Lot Number: 3861013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1