MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.75 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222333

Device Problem Mechanical Jam (2983)

Patient Problem Not Applicable (3189)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(6) that during a rotator cuff repair, the 4.75 healix advance kntlss pk pulled out after the insertion into the patient.According to the report, the surgeon believed that the anchor had extreme resistance when it was pulled out and that was the reason for the anchor to come out of the patient.Furthermore, the surgeon stated that probably the 4.75 healix advance kntlss pk were stuck together in the driver's handle.It was further reported that the resistance was between the anchor and the handle that it came off such that the anchor pulled out of the patient as the anchor didn't come off the handle properly.As a result, there was a 10 minute surgical delay.The procedure was completed with another device of a bigger size 5.5 hak due to the size of the remaining hole.It was reported that the patient outcome was expected to be normal.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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.Additional information: h6: method codes: device history lot : a manufacturing record evaluation was performed for the finished device lot number (4l88517), and no non-conformances were identified.Investigation summary : the complaint device is not being returned, it was discarded, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.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 (4l88517), 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: 4.75 HEALIX ADVANCE KNTLSS PK
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9495001
• MDR Text Key: 204702784
• Report Number: 1221934-2019-60052
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705023455
• UDI-Public: 10886705023455
• Combination Product (y/n): N
• PMA/PMN Number: K130539
• 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: 12/04/2019

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: 05/31/2022
• Device Model Number: 222333
• Device Catalogue Number: 222333
• Device Lot Number: 4L88517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1