MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RV RMR STRT PLT TIP

Catalog Number 321-25-01

Device Problem Break (1069)

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

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that while reaming the surgeon levered the pilot tip reamer against the glenoid and the tip broke.The wound was washed out and all fragments of the reamer were removed.This did not cause any delay to surgery.The patient was stable as they left the or.

Manufacturer Narrative

Section h10: (d4) catalog number: 321-25-01, lot number: 68106023, unique identifier (udi) #: (b)(4).(h3) based on capa2017-12, the broken device reported in case-2019-00001650 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.(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 section h11: *the following sections have corrected information: (d2) common device name: mdlr rv rmr strt plt tip.(g3) report source: check should of been added for health professional.No information provided in the following section(s): a2, a3, a4, a5, b6, b7, d6, d7, d11, g5, g8, h4.

• Brand Name: EQUINOXE
• Type of Device: MDLR RV RMR STRT PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9264689
• MDR Text Key: 189076570
• Report Number: 1038671-2019-00554
• 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: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-01
• Device Lot Number: 68106023
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2020
• 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