MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FASTIN RC 6.5MM OCORD W/O NDLS; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222994

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Not Applicable (3189)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional 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

This is report 1 of 2 for the same event.It was reported by the sales rep that during a rotator cuff repair surgery on (b)(6) 2020, it was observed that two anchor devices pulled out of the bone.Another like device was used to complete the surgery with a couple of minutes delay.There was an alternative product readily available.There were no 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 : the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (4l95781), and no non-conformance was identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: FASTIN RC 6.5MM OCORD W/O NDLS
• 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: 10508876
• MDR Text Key: 206191286
• Report Number: 1221934-2020-02450
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705008728
• UDI-Public: 10886705008728
• Combination Product (y/n): N
• PMA/PMN Number: K060664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 222994
• Device Catalogue Number: 222994
• Device Lot Number: 4L95781
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1