MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 6.5 HEALIX ADV SP PEEK CE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228057

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that the device could not be placed because of a packaging issue: the metallic charger with bleu handle was twisted whereas the anchor went out as usual.Impossibility to use the anchor without the kit.The complaint device is not being returned, 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 bent, the peek dilator and the anchor shows no structural damages, as a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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 unpacked the device may have pulled the blue threader tab while taking the device out of the foil pouch, therefore, the threader tab has been 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 the customer in france that during a rotator cuff repair procedure on (b)(6) 2021, it was observed that the 6.5 healix adv sp peek ce device could not be placed due to a packaging issue: the metallic charger with blue handle was twisted whereas the anchor went out as usual.During in-house engineering evaluation of the photo provided by the customer, it was determined that the threader tab on the device was bent.There was a delay of: less than five minutes in the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: 6.5 HEALIX ADV SP PEEK CE
• 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: 12102159
• MDR Text Key: 262661634
• Report Number: 1221934-2021-02062
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2021

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 Catalogue Number: 228057
• Device Lot Number: 7L24441
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1