MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HEALIX AV BR 5.5 TAPE BLUE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222361
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) incomplete.The expiration date is currently unavailable.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 or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown procedure on (b)(6) 2020, it was observed that the suture came off the anchor while being retracted from the joint with a retriever.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.The device was brand new and the first use when the issue occurred.
Additional 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.Investigation summary: according to the information received, it was reported that this was an unknown procedure performed on (b)(6) 2020.When the sutures of the anchor was being retracted from the joint with a retriever, the sutures came off the anchor.The complaint device is not being returned, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number: [6l96788], and no non-conformances were identified.Since the complaint device not being returned, 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, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.D4: the lot number was inadvertently left blank on the initial report; and has been updated to reflect the correct information.

• Brand Name: HEALIX AV BR 5.5 TAPE BLUE
• 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: 11089743
• Report Number: 1221934-2020-04134
• Device Sequence Number: 11653099
• Product Code: MAI
• UDI-Device Identifier: 10886705027811
• UDI-Public: 10886705027811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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 Model Number: 222361
• Device Catalogue Number: 222361
• Device Lot Number: 6L96788
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1