MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRIFXQA+ W/#4OC P3; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	212044
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a ligamentoplasty procedure on (b)(6) 2020, it was observed that when the suture was pulled, the anchor device came off.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
Additional 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: investigation summary : according to the information received, it was reported that during ligamentorraphy when the suture is pulled, the anchor comes off.The complaint device is not being returned.However, a photo was provided.Upon visual inspection of the photo, it was not clearly to see the condition of the device; but it was identified that the anchor was off the inserter.The complaint reported was confirmed.Hands on analysis should provide the evidence necessary to confirm the root cause.The possible root cause for the broken suture can be attributed to external excessive force and using sharp instruments during the surgery.However, it cannot be conclusively affirmed.As per ifu- 109285, do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.A manufacturing record evaluation was performed for the finished device lot number: 6l43014, and no nonconformances 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: MICRIFXQA+ W/#4OC P3
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11079708
• Report Number: 1221934-2020-04082
• Device Sequence Number: 3206879
• Product Code: MAI
• UDI-Device Identifier: 10886705001897
• UDI-Public: 10886705001897
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 212044
• Device Catalogue Number: 212044
• Device Lot Number: 6L43014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1