MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #4/0 ETH C-1; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	212866
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information received, the suture is not loaded on anchor.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received and picture provided by customer.Visual analysis of the returned device and picture received, when observed the anchor under magnification can be determined that the shaft inserter was broken.The silicon sleeve was found deformed in the distal part.A manufacturing record evaluation was performed for the finished device lot number: 4l67379, and no non-conformance's related to the reported complaint condition were identified.Based on the information currently available.Product evaluation of the returned device indicates that the device could have being broken due to excessive force applied during the procedure.As per ifu-(b)(4), indicate that do not use excessive tension to overload the anchor, as either could lead to device pullout or suture breakage.In this case, it can be concluded that root cause of the failure reported is due to excessive force applied during tensioning of the suture when was pulled, however; it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications at this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported from the affiliate that the micro qa suture would not load in the anchor.During an in-house engineering evaluation, it was determined that the device shaft inserter was broken and the silicon sleeve was found deformed in the distal part.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the procedure or whether a like device was available for use.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: MICRO QA+ #4/0 ETH C-1
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11657102
• Report Number: 1221934-2021-01183
• Device Sequence Number: 3520424
• Product Code: HWC
• UDI-Device Identifier: 10886705002535
• UDI-Public: 10886705002535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2021

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 Expiration Date: 04/30/2024
• Device Model Number: 212866
• Device Catalogue Number: 212866
• Device Lot Number: 4L67379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1