MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX BR 4.5 MM ANCHOR W/ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222229
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and evaluated.Visual examination revealed that the distal tip of the anchor was completely broken, confirming this complaint.The broken fragment was held in place by the suture.The anchor break occurred distal to the beginning of the first thread, indicating potential levering during insertion.Other typical causes of anchor breakages which may have contributed to this event include off axis 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 device history record indicated that this batch of product was processed without incident; therefore there is no internally assignable cause for the reported issue.Review of the depuy synthes mitek complaints system revealed other similar complaints for this lot 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.Udi: (b)(4).This report is being filed from the remetrex 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 from (b)(6) that during an unspecified surgical procedure, it was observed that the anchor device broke.It was not reported if there was a delay in the surgical procedure; however, it was reported that a spare device was used to complete the procedure in the same bone hole.It was reported that the broken piece was retrieved from patient.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: HEALIX BR 4.5 MM ANCHOR W/ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7669714
• Report Number: 1221934-2018-52908
• Device Sequence Number: 806213
• Product Code: MAI
• UDI-Device Identifier: 10886982156693
• UDI-Public: 10886982156693
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/27/2016

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: 03/31/2019
• Device Catalogue Number: 222229
• Device Lot Number: 3901136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2016
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1