MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	210133
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer in (b)(4) that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2021, it was observed that it was difficult to insert the rigidfix fem 3.3mm s/t xpin device into the guide and so it got stuck.During in-house engineering evaluation, it was determined that the sleeve and the trocar were found jammed.The procedure was competed with an unspecified delay.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).The lot was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name, and device manufacture date were unknown.Investigation summary: according to the information provided, it was reported that the it was difficult to insert the cutter into the guide and so it got stuck the device was received and evaluated.The sleeve and trocar were returned, which are part of the same kit.Upon visual inspection, the sleeve and the trocar were found jammed, it could be observed stretch marks all over the sleeve, also on the trocar.The two cross pins were not returned.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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 can be confirmed.The possible root cause for the jammed condition can be attributed to procedural variables, such handling of the device or product interaction during procedure; considering that the sleeve and the trocar has the stretch marks, we can relate this issue to a bad axis alignment of the drill at the moment of insertion, the bending force applied and the higher spinning speed of the drill can contribute to the jamming condition of the sleeve and the trocar.As per ifu 104144: directions for a successfully hole drilling and trocar and sleeve interaction 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.Document specification review: ifu 104144 rev: n.Device history lot: given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.Device history batch: null.Device history review: null.

• Brand Name: RIGIDFIX FEM 3.3MM S/T XPIN
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): 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: 13685530
• Report Number: 1221934-2022-00758
• Device Sequence Number: 5046068
• Product Code: HWC
• UDI-Device Identifier: 10886705000890
• UDI-Public: 10886705000890
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K974341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• 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 Model Number: 210133
• Device Catalogue Number: 210133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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