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 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It as reported that the physician had difficulty getting the reamer in due to patient anatomy.The tips broke off of each of these reamers.The tips did not remain in the patient and were removed before proceeding.The patient was stable upon leaving the operating room.

Manufacturer Narrative

Section h10: (h3) based on capa2017-12, the broken devices reported were likely the result of applying a bending moment to the reamers during use, which led to brittle fractures 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: z2663-2017, z2664-2017, z2665-2017, z2666-2017, z2667-2017, z2668-2017.

• 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: 9104366
• MDR Text Key: 164850260
• Report Number: 1038671-2019-00465
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862087614
• UDI-Public: 10885862087614
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-01
• Device Lot Number: 69697018
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 03/27/2020
• 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: 70 YR
• Patient Weight: 45