MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR CNLTD TRIDRV DRVR

Catalog Number 315-25-00

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

During a shoulder procedure on a male patient, the tri drive collar broke during glenoid reaming.Causing the need to change reamer handle and remove ball bearing and ring from open wound.During the same procedure, when impacting the glenoid, the glenoid impactor tip broke and also had parts removed from wound.No health complications from experience, just surgical delay.The patient was last known to be in stable condition following the event.Devices will return.Tri drive (315-25-00) stated on experience report is being captured under case (b)(4).

Manufacturer Narrative

The disassembled tri-drive handle reported was likely the result of the retaining ring responsible for maintaining assembly of the sleeve on the modular cannulated tri-drive shaft becoming deformed as a result of obstruction of the driver collar while reaming.

• Brand Name: EQUINOXE
• Type of Device: MDLR CNLTD TRIDRV DRVR
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 11342057
• MDR Text Key: 232342726
• Report Number: 1038671-2021-00052
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10885862251824
• UDI-Public: 10885862251824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315-25-00
• Device Lot Number: 259375025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male