MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR PRM RMR LG PLT TIP

Catalog Number 315-25-14

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, the surgeon was trying to use the large pilot reamer in a muscled patient and clipped the reamer on his posterior retractor.The reamer cracked on impact.No adverse impact on the patient.We used the smaller reamer to continue.

Manufacturer Narrative

(h3) the broken pilot tip reamer reported was likely the result of accidentally hitting the reamer with the posterior retractor during use, as stated in the experience report.

• Brand Name: EQUINOXE
• Type of Device: MDLR PRM RMR LG PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9734688
• MDR Text Key: 189079843
• Report Number: 1038671-2020-00212
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862085368
• UDI-Public: 10885862085368
• 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
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

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: 315-25-14
• Device Lot Number: 68106005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 05/18/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention