MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QUICKANCHOR PLUS #4-0 ORTHOCORD SUTURE (C-1 NEEDLE); SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	212041
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.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 a healthcare professional that during a hand ligament repair procedure on (b)(6) 2022, it was observed that the micro quickanchor plus #4-0 orthocord suture (c-1 needle) device would not fire.There were no adverse patient consequences nor surgical delay 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 nitial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations reveal the anchor was received separately from the inserter, but still attached in the suture.Finally, it was identified that the tip that holds the anchor in place where damage.No anomalies could be found on the drill bit.A manufacturing record evaluation was performed for the finished device lot number: 9l08995, and no nonconformances were identified.The possible root cause can be attribute when excessive force was applied while try to deploy the anchor causing damage in the inserter.However, it cannot be conclusively affirmed.As per ifu: the steps for proper anchor release are provided.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: MICRO QUICKANCHOR PLUS #4-0 ORTHOCORD SUTURE (C-1 NEEDLE)
• Common Device Name: 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15563024
• Report Number: 1221934-2022-03073
• Device Sequence Number: 15099402
• Product Code: HWC
• UDI-Device Identifier: 10886705001873
• UDI-Public: 10886705001873
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K080352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 01/31/2025
• Device Model Number: 212041
• Device Catalogue Number: 212041
• Device Lot Number: 9L08995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 11/15/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/12/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown