MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+ # 2-0 OC V5; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 212853

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Injury (2348); Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(6).(b)(4).

Event Description

It was reported by the affiliate that the anchors break and remain inside the patient the suture has burst and did not work.Product: 212044.Lot: 6l50324.Product: 212853.Lot: 6l18893.

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: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that there was a delay of 15 minutes in the procedure.It was reported that no additional anchors were used.It was reported that a new bone hole was used to pass another anchor.It was reported that no additional medical or surgical intervention was performed.The patient's current condition was reported to be unknown.

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.: investigation summary
=
> according to the information provided, it was reported that the anchors break and remain inside the patient, the suture had burst and did not work.The complaint device was implanted, therefore unavailable for a physical evaluation.Since the complaint was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [(b)(4)] number, 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: MINILOK QA+ # 2-0 OC V5
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10661478
• MDR Text Key: 211050154
• Report Number: 1221934-2020-02947
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705002429
• UDI-Public: 10886705002429
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2020

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: 08/31/2022
• Device Model Number: 212853
• Device Catalogue Number: 212853
• Device Lot Number: 6L18893
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/09/2020; 11/13/2020
• Supplement Dates FDA Received: 11/12/2020; 11/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention