MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX BR 3.4MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2016
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 complaint device was received and evaluated.Only a small fragment of the anchor was returned.The remainder of the anchor and the inserter were not returned.Based on the returned anchor fragment, this complaint can be confirmed.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality, or using incorrect instrumentation for preparing the bone hole; however, the root cause of this specific device failure cannot be conclusively determined.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 arthroscopic remplissage surgical procedure, it was observed that the healix br 3.4mm anchor device broke during use.According to the reporter, about 1/3 of the anchor broke, while the remaining 2/3 of anchor remained implanted inside the patient.It was reported that the broken part was retrieved out of the patient successfully.It was reported that the procedure was completed by using another similar anchor that was inserted.There was patient involvement.It was reported that the patient was stable.It was not reported if there was a delay in the surgical procedure.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.

• Brand Name: HEALIX BR 3.4MM
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8262285
• Report Number: 1221934-2019-56055
• Device Sequence Number: 2081026
• Product Code: MAI
• UDI-Device Identifier: 10886705023820
• UDI-Public: 10886705023820
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K150209
• 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): 08/23/2016

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 Expiration Date: 12/31/2018
• Device Catalogue Number: 222343
• Device Lot Number: 3885475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2016
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1