MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HEALIX AV BR 4.5 TAPE WHT/BLUE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222360
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Exp date is unknown.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.No additional information was provided.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an arthroscopic rotator cuff for a rotator cuff tear procedure on (b)(6) 2020, it was observed that the healix av br 4.5 tape blue device, when the surgeon pulled a suture from an inserter.Then, the anchor easily came off.He used the 2nd 4.5mm anchor, but the same event took place.Finally the procedure was completed with another replacement (5.5mm) less than 30-minute surgical delay was reported.There were no adverse patient consequences reported.No additional information was provided.
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.H10 additional narrative: d4, h4: the expiration and manufacture date were reported as unknown on the initial report.Both fields have been updated accordingly.Therefore, udi: (b)(4).Investigation summary: the complaint device is not being returned, it was retained 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 (6l57026), and no non-conformances related to the reported complaint condition 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.

• Brand Name: HEALIX AV BR 4.5 TAPE WHT/BLUE
• 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: 11041196
• Report Number: 1221934-2020-03959
• Device Sequence Number: 1265767
• Product Code: MAI
• UDI-Device Identifier: 10886705027804
• UDI-Public: 10886705027804
• 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): 12/03/2020

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: 12/31/2022
• Device Model Number: 222360
• Device Catalogue Number: 222360
• Device Lot Number: 6L57026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1