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

Model Number	222287
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
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).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 arthroscopy procedure on (b)(6) 2021, it was observed that the suture on the anchor device broke and was left within the patient.Another bone hole was created to pass another anchor to complete the procedure.There was a delay of 30 minutes in the procedure.The status of the patient post-surgery was unknown.No additional information was provided.
Event or Problem Description
It was reported by the affiliate in colombia that during an arthroscopy procedure on (b)(6) 2021, it was observed that the suture on the 4.75 healix advance kntlss br device broke and was left within the patient.Another bone hole was created to pass another anchor to complete the procedure.There was a delay of 30 minutes in the procedure.The status of the patient post-surgery was unknown.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 dates were reported as unknown on the initial report; and have been updated accordingly.Therefore, udi: (b)(4).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.A manufacturing record evaluation was performed for the finished device lot number (7l06558), 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.

• Brand Name: 4.75 HEALIX ADVANCE KNTLSS BR
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11594781
• Report Number: 1221934-2021-00968
• Device Sequence Number: 19889897
• Product Code: MBI
• UDI-Device Identifier: 10886705020393
• UDI-Public: 10886705020393
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K130917
• 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,Followup
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 222287
• Device Catalogue Number: 222330
• Device Lot Number: 7L06558
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 05/31/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/13/2021; 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention