MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX3 PEEK ANC.W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222207
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) - incomplete.The exp date is currently unavailable.Evaluation statement: two complaint devices were received and evaluated.Visual observations of the returned devices reveals stains and tissue debris on the distal ends of both anchors, the anchors for both devices were not cracked, but the threads and the distal tip were distressed.The sutures of one device were unfolded and removed from the suture card.No information was provided regarding the bone quality of the patient.Due to the tissue debris and stains, both of these anchors have been used and cannot be confirmed that the two anchors were damaged before insertion.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.A batch record review has been conducted and the results indicate that this batch of product was processed without incident as related the reported problem, and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed one other similar complaint for this lot of devices that were released to distribution.A root cause for the user to have experienced this issue cannot be determined.At this point in time, no further actions are warranted.However, depuy 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 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
This is report 2 of 3 for the same event.It was reported by the affiliate in (b)(6) that during rotator cuff neoplasty, it was observed that two screws were damaged and one was broken.The broken piece didn't fall into patient.It was reported that the surgeon changed the new replacements to complete the procedure.There was no adverse event or extended surgery.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: 5.5 HEALIX3 PEEK ANC.W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8241655
• Report Number: 1221934-2019-55979
• Device Sequence Number: 1929069
• Product Code: MAI
• UDI-Device Identifier: 10886705007554
• UDI-Public: 10886705007554
• 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): 07/23/2016

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 Catalogue Number: 222207
• Device Lot Number: 3709939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2016
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1