MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFX CRVE ST ACL PLA XPIN SYS; PIN, FIXATION, SMOOTH

Catalog Number 213013

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported by the healthcare professional in hungary that during an anterior cruciate ligament reconstruction procedure on an unknown date, it was observed that the guidewire got stuck in the sheath on the rigidfix curve st acl pla cross pin system device; and therefore was not used.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.

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: udi: (b)(4).The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.E3: reporter is a j&j sales representative.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.

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.The complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

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.Device was used for treatment, not diagnosis.H10 additional narrative: d4, h4: the lot number was unknown; therefore, the expiration date and device manufacture date were unknown in the initial medwatch report.The device information has been identified and updated accordingly.Investigation summary the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.The kit was received and evaluated; visual inspection revealed that, one of the sleeves and the trocar were found jammed, it could be observed stretch over the sleeve, also on the trocar.The rest of the kit does not show structural anomalies.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the rgdfx crve st acl pla xpin sys would have contributed to the complained issue.Based on the investigation findings, the possible root cause is traced to procedural variables, such handling of the device or product interaction during procedure; considering that the sleeve 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 trocar.As per ifu, directions for a successfully hole drilling and trocar and sleeve interaction are provided.Therefore, it has been determined that no corrective and/or preventative action is required.There was no non conformance regarding this lot number:128l664.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: RGDFX CRVE ST ACL PLA XPIN SYS
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17737122
• MDR Text Key: 323286768
• Report Number: 1221934-2023-03420
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K130105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213013
• Device Lot Number: 128L664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1