MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX BR 3.4MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2015
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 the anchor is broken in half.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.It was reported that the surgeon did not tap and was off angle when inserting the anchor.As stated in the product ifu; ¿inserting the awl/tap or drill bit less than the specified depth, axial misalignment or levering with the anchor upon insertion may result in anchor fracture¿.A review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.This failure can be attributed to user technique; failure to follow instructions for use.No corrective action is required and no further action is warranted at this time.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.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Udi: (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 by the sales rep that during a shoulder procedure when inserting the customer's healix br 3.4mm anchor, it was observed that the device broke in half.The sales rep stated that the surgeon removed the broken anchor with no issues.The sales rep stated that there was no debris left in the patient.The sales rep reported that the surgeon completed the procedure with another like device by tapping and using the same bone hole with no patient consequences but there was a two minute delay.The sales rep stated that he believes the anchor broke due to the surgeon was off angle and did not tap when inserting the anchor.The sales rep stated that the patient's bone quality was average and good bone.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: HEALIX BR 3.4MM
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7856617
• Report Number: 1221934-2018-51135
• Device Sequence Number: 13938227
• Product Code: MAI
• UDI-Device Identifier: 10886705023820
• UDI-Public: 10886705023820
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 222343
• Device Lot Number: 3801082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2015
• 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