MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMROD 9MM *EA; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	213709
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
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 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: e3: reporter is a j&j sales representative.D10: concomitant med products and therapy dates: rigidfix femoral st guide frame device, 11/28/2023.H4: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the sales rep that during an anterior cruciate ligament (acl) repair procedure on 11/28/2023, it was observed that the rigidfix femoral st guide frame n/s 1pk was bent/torqued and the drill sleeves and trocar were being prevented from crossing the window of the rigidfix femoral rod 9 mm 1pk.The distal sleeve eventually went across.The physician tried to reposition the guide for the proximal pin, after reapproximating the guide at a different angle, and redrilling, they were able to get the proximal pin through the frame.The skive marks were visible in the sleeve.There were no adverse consequences to the patient nor surgical delay reported.No additional information was provided.

• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: 18301042
• Report Number: 1221934-2023-04504
• Device Sequence Number: 19639652
• Product Code: FZX
• UDI-Device Identifier: 10886705003037
• UDI-Public: 10886705003037
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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 Catalogue Number: 213709
• Device Lot Number: 0086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown