MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX BR ANCHOR, 5.5 MM - W/ORTHOCORD & NEEDLES; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222232
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2013
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.Evaluation statement: the complaint device was received and evaluated.Visual observation confirms the anchor is broken above the second thread.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.However, no further information was provided to determine a root cause for the reported failure.A batch review was conducted and our results indicate that this batch was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, 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.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 by the affiliate that the device broke.

• Brand Name: HEALIX BR ANCHOR, 5.5 MM - W/ORTHOCORD & NEEDLES
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7802610
• Report Number: 1221934-2018-51890
• Device Sequence Number: 228850
• Product Code: MAI
• UDI-Device Identifier: 10886705007783
• UDI-Public: 10886705007783
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2013

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: 05/31/2016
• Device Catalogue Number: 222232
• Device Lot Number: 3706472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2013
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1