MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	212866
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
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).Investigation summary: the device was received and evaluated.Upon visual inspection, it was found that the anchor is detached from the inserter tip.Biological matter can be observed over the anchor, the suture and shaft.The slide cover on the handle was retracted, the suture is in good condition.The needles are in good condition, no structural anomalies can be observed.As no defect was found, a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.  as part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint cannot be confirmed.The customer reported needles that would not load, however the needles were found in good condition.No further information was provided by the customer, therefore we can not discern a root cause why the customer experienced the reported issue.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.Device history lot : as no defect was found, a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required. .
Event or Problem Description
It was reported by the customer that during an unknown surgery on (b)(6) 2022, it was observed that the micro quickanchor plus preloaded with 4/0 ethibond suture and c-1 needles would not load when they attempted to use it.During in-house engineering evaluation, biological matter could be observed over the anchor, the suture and shaft.Another device was used to complete the procedure.No patient consequences or surgical delay reported.

• Brand Name: MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES
• 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: 15838282
• Report Number: 1221934-2022-03673
• Device Sequence Number: 17583005
• Product Code: HWC
• UDI-Device Identifier: 10886705002535
• UDI-Public: 10886705002535
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K024115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 02/28/2023
• Device Model Number: 212866
• Device Catalogue Number: 212866
• Device Lot Number: L775667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2018
• 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