MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE BR3SUT W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 222296

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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).

Event Description

It was reported by affiliate via personal interaction that during arthroscopic rotator cuff repair,the anchors (4.75 healix advance kntlss br, 4.5 healix advance br3sut w/oc) were used for the rotator cuff bridge technique but came off the bone.Finally, the procedure was completed with replacements less than 30-minute surgical delay.No fragment was left in the patient's body.There was no harm to the patient.The devices were the first use when the issue occurred.The surgeon commented that the bone quality was inferior.Additional information provided by the affiliate reported the device will not be returned for evaluation and additional detail pertaining the event are not available.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (6l28715), and no non-conformances were identified.At this point in time, 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.

• Brand Name: 4.5 HEALIX ADVANCE BR3SUT W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10196562
• MDR Text Key: 197572814
• Report Number: 1221934-2020-01636
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705021321
• UDI-Public: 10886705021321
• Combination Product (y/n): N
• PMA/PMN Number: K120078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

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 Expiration Date: 08/31/2022
• Device Model Number: 222296
• Device Catalogue Number: 222296
• Device Lot Number: 6L28715
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 06/29/2020
• Patient Sequence Number: 1