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

Catalog Number 222330

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is unknown.

Event Description

It was reported by the sales rep via cst that during a rotator cuff reconstruction surgery, at the time of the passage for the double row, a 4.5-liter pass is passed, but the anchor is not grasped and sold from the hole, and the handle is sold from the anchor, without it remaining good grip, the anchor must be removed and the titanium anchors passed.The surgery was delayed by 15 minutes, the procedure has been completed.

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.Additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part number, lot number combination per qlik query executed on (b)(6)2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Device history: no nonconformances were identified for this part number, lot number combination per qlik query executed on (b)(6)2019.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.

• Brand Name: 4.75 HEALIX ADVANCE KNTLSS BR
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8972315
• MDR Text Key: 161017729
• Report Number: 1221934-2019-58216
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705023462
• UDI-Public: 10886705023462
• Combination Product (y/n): N
• PMA/PMN Number: K130917
• 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: 08/09/2019

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 Catalogue Number: 222330
• Device Lot Number: 2L06445
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/06/2019
• Patient Sequence Number: 1