MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; STARTER PILOT TIP REAMER BOW TIE

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that during a reverse surgery arthroplasty, while reaming the glenoid, the resident in the case broke pilot tip on the starter reamer.The broken tip was removed from the patient and this was verified via fluoroscopy.The patient was stable as they left the or.

Manufacturer Narrative

Section h10: (h3) based on capa2017-12, the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip feature.(h6) evaluation codes: 2199, 1069.(h7) recall.(h9) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z-2663-2017, z-2664-2017, z-2665-2017, z-2666-2017, z-2667-2017, z-2668-2017.

• Brand Name: EQUINOXE
• Type of Device: STARTER PILOT TIP REAMER BOW TIE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9144711
• MDR Text Key: 189075236
• Report Number: 1038671-2019-00479
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 81