MAUDE Adverse Event Report: DEPUY MITEK 6.5 HEALIX ADVANCE BR3SUT W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 222301

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.(b)(4) - incomplete.The expiration date is currently unavailable.See associated medwatch: 1221934-2018-50007.

Event Description

It was reported that the healix advance br6.5 was used during the rotator cuff repair on (b)(6) 2017.The surgeon had a difficulty in inserting it smoothly.When the surgeon pushed it in harder, the anchor was detached.It was brand new and the first use when the issue occurred.There was a 10-minute delay in surgery and no harm to the patient.This is report 2 of 2 for (b)(4).

Event Description

Additional information received from affiliate on 26 november 2018: the devices will not be returned.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Evaluation statement: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, no corrective action is required and no further action 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).The expiration date is not currently available.Associated medwatch report number: 1221934-2018-50007.

• Brand Name: 6.5 HEALIX ADVANCE BR3SUT W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7159674
• MDR Text Key: 96503797
• Report Number: 1221934-2018-50008
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• PMA/PMN Number: K120078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 222301
• Device Lot Number: L437146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1