MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE BR ORTHO&NDLS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222299
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2015
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 observation confirms that the anchor is broken at the distal end and the second thread on the anchor is stripped.There is no other damage to the anchor and the suture bridge is intact.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 review was conducted and the 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 similar complaint for this lot released to distribution.It was reported that the insertion was not off axis, and the patient had a normal bone quality.The lot review indicates there were no issues with material or assembly.Although the complaint can be confirmed, a root cause for the user to have experienced this issue cannot be determined.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 (b)(4) 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 arthroscopy, it was observed that the anchor broke during insertion.It was reported that all parts were removed.The procedure was completed with same like product with a 10 minute delay.It was reported that the insertion was not off axis and the patient had normal bone quality.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 HEALIX ADVANCE BR ORTHO&NDLS
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7855156
• Report Number: 1221934-2018-50939
• Device Sequence Number: 1271906
• Product Code: MAI
• UDI-Device Identifier: 10886705021352
• UDI-Public: 10886705021352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120078
• 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): 11/18/2015

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: 05/31/2018
• Device Catalogue Number: 222299
• Device Lot Number: 3847665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2015
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1