MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5MM HEALX ADV SP BIOC ANCHOR; SOFT TISSUE ANCHOR, BIOABSORBABLE

Model Number 222424

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during a shoulder scope a 5.5mm healx adv sp biocomposite anchor was opened and the scrub tech noticed the threader tab was not fully loaded and was too curl up to advance the kites out the tip of the anchor.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However a photo was provided.Upon visual inspection of the photo, it was observed that the device's threader tab is deformed.A manufacturing record evaluation was performed for the finished device (b)(4) 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 of the photo, this complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure, the person who unpackaged the device may pulled the blue threader tab while removing the device out of the aluminum bag, therefore, the threader tab was deformed, however, this cannot be conclusively determined.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 Description

It was reported by sales rep that during a shoulder scope procedure on (b)(6) 2021, it was observed that the threader tab on the 5.5mm healx adv sp biocomposite anchor device was not fully loaded and was too curl up to advance the kites out the tip of the anchor.During in-house engineering evaluation of the photo provided by the customer, it was determined that the threader tab on the device was deformed.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: 5.5MM HEALX ADV SP BIOC ANCHOR
• Type of Device: SOFT TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• 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: 12031854
• MDR Text Key: 257231026
• Report Number: 1221934-2021-01930
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705030590
• UDI-Public: 10886705030590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2021

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 Expiration Date: 08/31/2023
• Device Model Number: 222424
• Device Catalogue Number: 222424
• Initial Date Manufacturer Received: 06/19/2021
• Initial Date FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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