MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFIX FEM3.3MM ST BR XPIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	210816
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 sales rep in (b)(6) that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2021, it was observed that the rigidfix biocryl 3.3 mm femoral st cross pin kit device was fused on the sleeve while doing the holes for rigidfix cross pin.Another like device was used to complete the procedure with a delay of five minutes.There were no adverse patient consequences 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 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 mdwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that the drill bit fused on the sleeve, while doing the wholes for rigidfix cross pin.The complaint device is not being returned, therefore unavailable for a physical evaluation.However the customer provided a photo which is showing the trocar and sleeve jammed, also, it was observed stretch marks over the two devices.As 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 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 109648: 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.
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: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary: according to the information provided, it was reported that the drill bit fused on the sleeve, while doing the wholes for rigidfix cross pin.The complaint device is not being returned, therefore unavailable for a physical evaluation.However the customer provided a photo which is showing the trocar and sleeve jammed, also, it was observed stretch marks over the two devices.A manufacturing record evaluation was performed for the finished device 6l40862 number, and no non-conformances were identified.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 109648: 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.

• Brand Name: RGDFIX FEM3.3MM ST BR XPIN KIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11977727
• Report Number: 1221934-2021-01849
• Device Sequence Number: 17000496
• Product Code: MAI
• UDI-Device Identifier: 10886705001309
• UDI-Public: 10886705001309
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K150209
• 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): 05/28/2021

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: 09/30/2022
• Device Model Number: 210816
• Device Catalogue Number: 210816
• Device Lot Number: 6L40862
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 07/28/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 06/29/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1