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

Model Number	212044
Medical Device Problem Codes	Use of Device Problem (1670); Residue After Decontamination (2325); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information provided, it was reported that the thread skipped when the surgeon was going to fix it.The device was received and evaluated.Upon visual inspection, it was observed that the suture is broken from the part that holds the anchor.The device is impregnated with rests of biological matter.The returned needle is in good condition.The anchor was not returned.A manufacturing record evaluation was performed for the finished device 7l49655 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure, the suture may have been in contact with surgical instruments, also, the operator may applied excessive tension to the suture at the moment of tightening; as per ifu 109285; as with any suture anchor device, care should be taken to avoid suture damage during insertion.Bony surfaces that may contact the suture should be smoothed to avoid nicking.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.Excessive tension may overload the anchor or suture.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an orthopedic procedure on (b)(6) 2021, it was observed that the thread on the device skipped when the surgeon was going to fix it.During in-house engineering evaluation, it was determined that the suture was broken from the part that held the anchor.It was further determined that the device was impregnated with rests of biological matter.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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: 12698631
• Report Number: 1221934-2021-03126
• Device Sequence Number: 3705975
• 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
• Report Date (Section B): 10/25/2021

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: 10/31/2023
• Device Model Number: 212044
• Device Catalogue Number: 212044
• Device Lot Number: 7L49655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1