MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5 HEALIX ADV SP PEEK CE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 228056

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep in (b)(6) that during an arthroscopic shoulder stabilization procedure on (b)(6) 2021, it was observed that the thread pass on the 5.5mm healix advance sp peek anchor device was twisted that it was looking down and would not move.It was further reported that the anchor was already slipped.They put it back in place and managed to load 4 strands with difficulty.The procedure was completed with a surgical delay of two minutes.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : according to the information provided, it was reported that during an arthroscopic shoulder stabiliz the 5.5mm healix advance sp peek anchor had its kit / thread pass twisted.It was looking down.Could not move.Opening the box was not easy but the kit was already twisted and the anchor was already slipped.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, four photos were provided.Upon visual inspection of the photos, it was observed that the device's threader tab is bent, the peek dilator and the anchor shows no structural damages, an arthroscopic image can be observed at the moment the sutures are been tightened, another photo is showing the patient's shoulder when tightening the sutures.A manufacturing record evaluation was performed for the finished device 7l07043 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 photos, 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.

• Brand Name: 5.5 HEALIX ADV SP PEEK CE
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11800959
• MDR Text Key: 261980598
• Report Number: 1221934-2021-01493
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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: 06/30/2023
• Device Catalogue Number: 228056
• Device Lot Number: 7L07043
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1