MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIXADV BR 5PK-3SUTURE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) - incomplete.The expiration date is not currently available.
Event or Problem Description
It was reported by our sales rep that while attempting a rotator cuff repair on (b)(6) 2018, one of our 4.5mm healix advance br anchors failed to purchase in the patient¿s bone.The (b)(6) had begun to tie knots on the medial row, and had gotten to his final knot to tie, when we noticed a sharp recoil.Originally thought to be a ruptured suture, we noticed that the healix anchor had pulled out of the bone.Clearly noticeable was a vertical break in the cortical threads of the anchor, as one side of the anchor had completely broken free from the rest of the anchor.The (b)(6) then proceeded to place a 6.5 healix advance anchor in the patient and the procedure went as expected with no further delays.No adverse patient events occurred either.There is no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was discarded by the customer, therefore unavailable for a physical evaluation.The complaint cannot be confirmed.We cannot discern a root cause for the reported failure due to insufficient information provided.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.At this point in time, no corrective action is required and no further actions is warranted.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.Udi: (b)(4).

• Brand Name: 4.5 HEALIXADV BR 5PK-3SUTURE
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7579068
• Report Number: 1221934-2018-51484
• Device Sequence Number: 18884438
• Product Code: MAI
• UDI-Device Identifier: 10886705021482
• UDI-Public: 10886705021482
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K120078
• 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,Followup
• Report Date (Section B): 06/20/2018

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: 09/30/2020
• Device Catalogue Number: 222320
• Device Lot Number: L604132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1