MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.75MM HEALIX KNOTLESS BR; SOFT-TISSUE ANCHOR, BIODEGRADABLE

Catalog Number	222286
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2013
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 device is not being returned, therefore is unavailable for a physical evaluation.A batch 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 and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed 1 similar complaint for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is 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.(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
The sales representative reported that her healix knotless anchor 4.75 mm broke while being inserted into the bone hole during a rotator cuff procedure.The surgeon was able to completely remove the anchor.The surgeon inserted another healix anchor into the bone hole but had to remove the inserter to find the original bone hole and as he did this the second anchor fell off the inserter onto the floor.The surgeon then used a competitor's device to complete the procedure with no patient consequences but with a ten (10) minute delay.The sales representative verified that the bone quality was average.The surgeon used the yellow handled healix awl.She also confirmed the surgeon was not off axis and there was no audible sound that the anchor broke.The devices were discarded.

• Brand Name: 4.75MM HEALIX KNOTLESS BR
• Common Device Name: SOFT-TISSUE ANCHOR, BIODEGRADABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7621817
• Report Number: 1221934-2018-50794
• Device Sequence Number: 19181624
• Product Code: MAI
• UDI-Device Identifier: 10886705020386
• UDI-Public: 10886705020386
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K112249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2013

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: 01/01/2015
• Device Catalogue Number: 222286
• Device Lot Number: 3589731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2013
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1