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	10/07/2013
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.The complaint devices were received and evaluated.Visual observation reveals that the received anchor is broken transversally along the cancellous threads.This complaint can be confirmed anchor breakages are typically associated with off axis insertion, levering during insertion, or using incorrect instrumentation for preparing bone hole.The ifu instructs using an awl-tap for this anchor.Using only an awl in a good/hard bone could lead to an increased risk of anchor breakage while inserting.There was no information reported on the tools used to prepare the bone.A batch review was conducted to determine if there were any internal processing issues, which would have contributed to the nature of the product complaint.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 of any type for this lot of devices that were released to distribution.We cannot discern a root cause for this failure.Based on the overall complaint rate for this failure, at this point in time, 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 affiliate that the anchor broke when it was being introduced into the patient.

• 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: 7693795
• Report Number: 1221934-2018-51345
• Device Sequence Number: 1108280
• Product Code: MAI
• UDI-Device Identifier: 10886705007783
• UDI-Public: 10886705007783
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/10/2013

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: 04/23/2016
• Device Catalogue Number: 222232
• Device Lot Number: 3687964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2013
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR