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

Model Number 212044

Device Problems Break (1069); Device Damaged Prior to Use (2284); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary : according to the information provided, it was reported that when uncovering the reference anchor and trying to be placed by the specialist we realize that the anchor came defective at the factory and could not be placed, the device was received and evaluated.Upon visual inspection, it was observed that the anchor is not attached onto the inserter, at magnification, it was revealed that the inserter tip is broken and the broken inserter tip remains inside the anchor, also, the anchor and suture are impregnated with biological matter which can be related to the moment the operator held the device to insert the anchor.The sutures, inserter shaft and the anchor have no structural anomalies.A manufacturing record evaluation was performed for the finished device 7l24474 number, and no non-conformance 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 cannot be confirmed.The customer is complaining about a factory related issue, however, the customer did not provide more details in regards the defect they found.The results of our investigation did not revealed structural anomalies with the device.In regards the broken inserter tip, the possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure.As per ifu 109285; do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.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.Document specification review: ifu 109285 rev.H.Device history lot : please provide mre, product code: 212044, lot/sn: (b)(4), there was no non-conformance.Manufacturing date: 28 aug 2020, expiry date: 31 jul 2023, quantity: (b)(4), release date: 18 sep 2020.Device history batch: null.Device history review : null.

Event Description

It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the micrifxqa+ w/#4oc p3 anchor device was defective upon opening its package.During in-house engineering evaluation, it was observed that the inserter tip was broken; and both the anchor and suture on the device were impregnated with biological matter.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: MICRIFXQA+ W/#4OC P3
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12846372
• MDR Text Key: 283842875
• Report Number: 1221934-2021-03378
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001897
• UDI-Public: 10886705001897
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 212044
• Device Catalogue Number: 212044
• Device Lot Number: 7L24474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female