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

Catalog Number	315-25-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2021-00052
• Device Sequence Number: 17351422
• Product Code: LXH
• UDI-Device Identifier: 10885862251824
• UDI-Public: 10885862251824
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male