MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.75 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222333

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

Event Type  malfunction  

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).Investigation summary: the complaint device is not being returned, it was discarded 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 (8l17202), and no non-conformances 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 Description

It was reported by the sales rep that during an unknown surgery on (b)(6) 2021, it was observed that the tip on the anchor on the 4.75 healix advance kntlss pk device bent upon insertion into the hole that it rendered the bridge of the sutures and the rest of the anchor worthless.Another like device was used to complete the procedure with a delay of five minutes there were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: 4.75 HEALIX ADVANCE KNTLSS PK
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12554532
• MDR Text Key: 274064255
• Report Number: 1221934-2021-02855
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705023455
• UDI-Public: 10886705023455
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 222333
• Device Catalogue Number: 222333
• Device Lot Number: 8L17202
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1