MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 6.5 HEALIX ADVANCE KNTLS BR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222583
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).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 (8l06941), 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.
Event or Problem Description
It was reported by sales rep that during a rotator cuff repair procedure on (b)(6) 2021, it was observed that 6.5 healix advance knotlesss br anchor device broke at the nose when trying to pass the suture through it.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: 6.5 HEALIX ADVANCE KNTLS BR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12225527
• Report Number: 1221934-2021-02237
• Device Sequence Number: 4487396
• Product Code: MAI
• UDI-Device Identifier: 10886705030323
• UDI-Public: 10886705030323
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 222583
• Device Catalogue Number: 222583
• Device Lot Number: 8L06941
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1