MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222334
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	08/10/2017
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 investigation summary: the complaint device is not being returned, it has been discarded.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.Furthermore, a review into the depuy synthes mitek complaints system revealed no similar complaints of any kind 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.A device history record review has been 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 of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.However, depuy synthes 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) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported during a shoulder scope/rotator cuff repair the healix advance knotless peek anchor 5.5 mm would not advance into the bone.The anchor was removed with no issues.The patient was reported to have soft/poor bone quality.The procedure was completed using a like device.There was a two minute delay in surgery.There was no patient consequence.This is report 1 of 1 for (b)(4).

• Brand Name: 5.5 HEALIX ADVANCE KNTLSS PK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8281513
• Report Number: 1221934-2018-53901
• Device Sequence Number: 18873887
• Product Code: MBI
• UDI-Device Identifier: 10886705023486
• UDI-Public: 10886705023486
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2017

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: 04/30/2020
• Device Catalogue Number: 222334
• Device Lot Number: L393382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1