MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIXADV BR ANC PCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	223128
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2015
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 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 with an unrelated non-conformance to the reported incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints revealed one other 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.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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 etq 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 sales rep that during a rotator cuff procedure after the surgeon inserted the customer's 4.5 healix advance with permacord br, the anchor broke in half horizontal and pulled out when tying the suture.The sales rep stated that the surgeon removed the broken anchor and no debris was left in the patient.The sales rep stated that the anchor looked defected and that where the thread is, it appears that it was not molded properly.The sales rep reported that the surgeon completed the procedure with a 5.5 healix advance anchor using the same bone hole with no patient consequences but there was a five minute delay.The sales rep stated that the end result was fine and doctor was ok with the outcome.The sales rep stated that the device was discarded.

• Brand Name: 4.5 HEALIXADV BR ANC PCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7796276
• Report Number: 1221934-2018-51042
• Device Sequence Number: 2336392
• Product Code: MAI
• UDI-Device Identifier: 10886705024803
• UDI-Public: 10886705024803
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/17/2015

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 Catalogue Number: 223128
• Device Lot Number: 3761979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2015
• Initial Report FDA Received Date: 08/19/2018
• Patient Sequence Number: 1