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 Problems Injury (2348); Not Applicable (3189)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

It was reported by the affiliate via email that the anchor was backed out when the surgeon applied the tension to the suture during an arcr surgery.The anchor tip got the crack, so that the surgeon attempted to implant the anchor by using alternative anchor.However, the alternative anchor was also backed out so that the surgeon attempted to implant the 3rd anchor with different bone hole to be opened.Then, the 3rd anchor was also broken at the tip of the anchor.Finally, the surgeon used alternative anchor to complete the surgery.It was brand new and the first use when the issue occurred.There was less than 30min.Surgical delay and no harm to the patient.Additional information received from the affiliate on 01/24/2019 reporting that the impacted devices would not be returning to depuy mitek for evaluation.

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint indicates that the device will not be returned and therefore not available for evaluation.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.We cannot discern a root cause for the reported failure mode.No nonconformances were identified for this part number, serial number combination.Review conducted per qlik query executed on 2/13/2019.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.Udi: (b)(4).

• 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: 8333606
• MDR Text Key: 136021786
• Report Number: 1221934-2019-56388
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 222330
• Device Lot Number: L883012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/14/2019
• Patient Sequence Number: 1