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

Model Number 212853

Device Problems Migration or Expulsion of Device (1395); Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); Not Applicable (3189)

Event Date 09/28/2020

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)(4).

Event Description

It was reported by the affiliate an anchor (mini lok quick anchor 2.3mm orthocord # 2/0) was used at the beginning of the surgery, this was defective since the suture did not slide through the anchor, in addition the anchor came out of the bone and no kind of force had been made.The mini anchor was sent with needles included in its corresponding packaging as evidence and for review.

Event Description

It was reported by the affiliate in colombia that during an unknown surgery on an unknown date, it was observed that the suture did not slide through the anchor device.Furthermore, it was reported that the anchor came out of the bone even without any force made.It was reported that the procedure was completed successfully as it was possible to place two more mini anchors made of titanium.It was reported that a replacement anchor used which was a mini quick anchor 1.8mm ortho anchor.It was reported that a new anchor was not placed in the same bone hole.It was reported that there was an unspecified surgical delay to have another treatment option that the surgeon was satisfied.It was reported that the patient's outcome was optimal.All available information has been disclosed.If additional information becomes available, a supplemental medwatch will be submitted accordingly.

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.B1, b2, b5 and h1: subsequent follow-up with the customer, additional information was received.It was reported that the procedure was completed successfully as it was possible to place two more mini anchors made of titanium.It was reported that a replacement anchor used which was a mini quick anchor 1.8mm ortho anchor.It was reported that a new anchor was not placed in the same bone hole.It was reported that there was an unspecified surgical delay to have another treatment option that the surgeon was satisfied.It was reported that the patient's outcome was optimal.Based on this additional information, b1, b2, b5, and h1 fields have been updated accordingly.

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: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.According to the information provided, it was reported that an anchor (mini lok quick anchor 2.3mm orthocord # 2/0) was used at the beginning of the surgery, this was defective since the suture did not slide through the anchor, in addition the anchor came out of the bone and no kind of force had been made.The complaint device was received and inspected.Visual inspection confirms that the mini anchor was found detached from the shaft inserter.In addition, one suture was found cutted and the suture card was missing.The complaint can be confirmed.The possible root cause can be attributed to incomplete insertion into the bone hole or poor bone quality for cutted suture can be associated with instruments used in handling the suture had sharp edges.However, it cannot be conclusively affirmed.The sterile load information was reviewed to see if there were any other complaints were the anchor came out of the bone for any products sterilized in the same load.There were 42 different lots of product containing 9258 devices.A review of the complaint files revealed that there were no other complaints about patient related to the lot number involved in this complaint (5l13472).The review of the complaint files revealed there were no other complaints in which the anchor came out of the bone was reported for a different lot number in the same sterile load.The eto sterilization of the device has been done according to requirements of iso 11135:2014.The certificate of sterilization indicates that the physical acceptance criteria and microbiological acceptance criteria were in compliance with the validated specifications.A manufacturing record evaluation was performed for the finished device lot number:5l13472, 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: 10696716
• MDR Text Key: 211872063
• Report Number: 1221934-2020-03050
• 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,Followup,Followup
• Report Date: 09/29/2020

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: 06/30/2022
• Device Model Number: 212853
• Device Catalogue Number: 212853
• Device Lot Number: 5L13472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 11/06/2020; 10/14/2020; 11/29/2020; 12/15/2020
• Supplement Dates FDA Received: 11/09/2020; 11/11/2020; 11/30/2020; 12/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention