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

Model Number	222359
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The expiration date is currently unavailable.Investigation summary: according to the information provided, it was reported that after the anchor was inserted, the surgeon made sure if the tape could slide by pulling its end.As the tape did not slide, he pulled the tape with a little more load.The pulling direction was correct, but the anchor came out of the burr hole.The anchor was removed, and a replacement was applied into the same burr hole.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.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.Manufacturing record evaluation was performed for the finished device lot number:6l96787, 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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an arthroscopic rotator cuff repair procedure on (b)(6) 2021, it was observed that the healix av br 4.5 tape blue anchor device came out of the burr hole as the surgeon pulled the end of the tape.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 its first use when the issue occurred.

• Brand Name: HEALIX AV BR 4.5 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: 11339578
• Report Number: 1221934-2021-00562
• Device Sequence Number: 11606227
• Product Code: MAI
• UDI-Device Identifier: 10886705027798
• UDI-Public: 10886705027798
• 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
• Report Date (Section B): 02/03/2021

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: 222359
• Device Catalogue Number: 222359
• Device Lot Number: 6L96787
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1