MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MDLR RV RMR 38MM PLT TIP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that during an initial procedure, a reamer and tri-driver broke.No parts or pieces fell into the patient.There was no surgical delay.The devices were returned.
Event or Problem Description
The reamer got stuck in the shaft couldn¿t be removed.It didn¿t affect the case outcome or patient outcome.Patient was last known to be in stable condition following the event.This event is no longer considered to be a reportable event as no device fracture occurred.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: b5 after review of additional information received the following section, was corrected accordingly: h1 -type of reportable event.

• Brand Name: EQUINOXE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16588343
• Report Number: 1038671-2023-00482
• Device Sequence Number: 6067787
• Product Code: LXH
• UDI-Device Identifier: 10885862087621
• UDI-Public: 10885862087621
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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 Model Number: MDLR RV RMR 38MM PLT TIP
• Device Catalogue Number: 321-25-38
• Device Lot Number: 148508005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 03/22/2023
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 315-25-00 MDLR CNLTD TRIDRV DRVR - 920210
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown