MAUDE Adverse Event Report: DEPUY MITEK 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	12/03/2014
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 only the inserter with the sutures came back for evaluation.The anchor itself didn¿t come back.The inserter and sutures were examined and no anomalies were found that would lead to the reported failure.This complaint cannot be confirmed.Anchor breakages are typically associated with off axis insertion, levering during insertion, or using incorrect instrumentation for preparing bone hole.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 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.(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 by the affiliate in (b)(6) that during shoulder repair surgical procedure, it was observed that the tip of lupine ancho broke in the patient at the time of introduction.It was reported that it replaced by another anchor lupine.It was not reported if there were any delays in the 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 ANCHOR, 5.5 MM - W/ORTHOCORD & NEEDLES
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7742710
• Report Number: 1221934-2018-53004
• Device Sequence Number: 11103823
• 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
• Type of Report: Initial
• Report Date (Section B): 12/09/2014

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: 02/01/2017
• Device Catalogue Number: 222232
• Device Lot Number: 3765757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2014
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1