MAUDE Adverse Event Report: DEPUY MITEK LLC US 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	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.Investigation summary: the complaint device is not being returned, it was implanted in the patient, 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.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.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 tape came off on the healix av br 5.5 tape blue device.Another like device was used to complete the procedure with an hour 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 5.5 TAPE BLUE
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11876471
• Report Number: 1221934-2021-01642
• Device Sequence Number: 19665204
• 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
• Report Date (Section B): 05/13/2021

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: 222361
• Device Catalogue Number: 222361
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1