MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX BR ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222233
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2014
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.Evaluation statement: the complaint device was received and evaluated.Visual observation confirms that the distal half of the anchor is broken.When observed under magnification, no structural anomalies were observed that could have contributed to this failure.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.However, it was reported that none of the above reasons contributed to this event.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 one similar complaint for this lot of devices that were released to distribution.From the information provided, a root cause for this failure cannot be determined.Based on the 12 month 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.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 that dr.(b)(6) used our tap to make a hole for the 5.5 mm healix br anchor with orthocord.Anchor was fitted into the hole and with the second turn the anchor broke.We used a nebular and the point for the healix all to brake the piece of the anchor that stayed behind out of the shoulder.The surgeon repositioned the hole and used a healix peek anchor to complete the procedure.We had to brake the part of the anchor that was left in the shoulder out.Made new placement sight and replaced with healix peek.

• Brand Name: 5.5 HEALIX BR ANCHOR 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: 7813332
• Report Number: 1221934-2018-53316
• Device Sequence Number: 11097209
• Product Code: MAI
• UDI-Device Identifier: 10886705007790
• UDI-Public: 10886705007790
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2014

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: 09/30/2016
• Device Catalogue Number: 222233
• Device Lot Number: 3726913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2014
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1