MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 5.5 HEALIX ADVANCE KNTLS BR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222582
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint, and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [6l75707] number, and no non-conformances were 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 the sales rep that during an unknown procedure on (b)(6) 2020, it was observed that the 5.5 healix advance kntls br device broke while trying to place the suture through it.Another like device was used to complete the procedure with no surgical delay, or patient consequences.No additional information was provided.

• Brand Name: 5.5 HEALIX ADVANCE KNTLS BR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11055052
• Report Number: 1221934-2020-03995
• Device Sequence Number: 19479545
• Product Code: MAI
• UDI-Device Identifier: 10886705030316
• UDI-Public: 10886705030316
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

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: 02/28/2023
• Device Model Number: 222582
• Device Catalogue Number: 222582
• Device Lot Number: 6L75707
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1