MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.75 HEALIX ADVANCE KNTLS BR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222581
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4) incomplete.The expiration date is currently unavailable.Investigation summary: according to the information received, it was reported that during a subscapularis repair two 4.75 healix advance knotless br broke.No surgical delay or patient consequences reported.No fragments were generated.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number: 7l74477, and no non-conformances were identified.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.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.Device history lot: product code: 222581, lot/sn: (b)(4).There was no non conformance regarding this lot.Manufacturing date:20 jan 2021.Release date:04 feb 2021.Expiry date: 31 dec 2023, quantity: (b)(4).
Event or Problem Description
It was reported by sales rep that during a subscapularis repair procedure on (b)(6) 2021, it was observed that the anchor device broke.There were no fragments were generated.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: 4.75 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: 11614819
• Report Number: 1221934-2021-01085
• Device Sequence Number: 14202838
• Product Code: MAI
• UDI-Device Identifier: 10886705030309
• UDI-Public: 10886705030309
• Combination Product (Y/N): N
• 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): 03/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 222581
• Device Catalogue Number: 222581
• Device Lot Number: 7L74477
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1