MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX PEEK ANCH.W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 222205

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Incomplete.The expiration date is currently unavailable.Investigation summary: according to the information received, during the surgery of rotator cuff repair surgery, opened the packing(did not use), noted the thread of anchor was pealed (as the photo shows).The device was received and evaluated.Upon visual inspection, it was found that the suture holder card is out of its compartment, and it has biological rests well as the inserter handle.The sutures were reviewed, no anomalies were found, however, they are not attached on the holder card.The anchor was inspected under magnification, it was found that the anchor has biological rests on its body.The tip of the anchor was found to be damaged as well as a couple of threads.When reviewing the inserter shaft, it was found a few stretch marks in spiral, which is a sign that the anchor was inserted and threaded.The customer provided a photo, it was found that the anchor has a damaged thread and biological rests at the tip.A manufacturing record evaluation was performed for the finished device lot number:7l20769, and no non-conformances related to the reported complaint condition were identified.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The root cause for the reported issue can be attributed to a mishandling of the device and bending force applied at the moment of insertion.As per ifu (b)(4): axial misalignment or levering with the anchor upon insertion, may result in anchor fracture.Do not apply a bending force to the inserter.This can damage the anchor or inserter tip.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

Event Description

It was reported by the affiliate in (b)(6) that during a rotator cuff repair procedure on (b)(6) 2021, it was observed that the thread on the 4.5 healix peek anch.W/ocord anchor device was peeled upon opening its package.During in-house engineering evaluation, it was determined that the suture holder card was out of its compartment and had biological residues as well as the inserter handle.It was further determined that the anchor had biological residues on its body and its tip was threaded.It was further determined that the inserter shaft had a few stretch marks in spiral, which was a sign that the anchor was inserted and threaded.Another like device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Brand Name: 4.5 HEALIX PEEK ANCH.W/OCORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11785714
• MDR Text Key: 264143255
• Report Number: 1221934-2021-01431
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705007530
• UDI-Public: 10886705007530
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2021

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
• Device Operator: Health Professional
• Device Model Number: 222205
• Device Catalogue Number: 222205
• Device Lot Number: 7L20769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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