MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	EQUINOXE REVERSE SHOULDER DRILL KIT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that during an initial implant procedure, when attempting to drill a hole for the reverse baseplate, the drill bit unfortunately snapped off within the drill guide.No parts or pieces fell into the wound site.Patient was last known to be in stable condition following the event.The device is available for return.
Additional Manufacturer Narrative
Based on historical complaint investigations and the returned devices, the jammed devices reported were likely the result of applying a bending moment to the drill bit, which led to deformation on the inner surface of the drill guide and outer surface of the drill bit which led to galling and eventually prevented the drill bit from passing through.The broken drill bit was likely the result of applying a bending moment while drilling and during an attempt to remove the drill from the drill guide, which led to ultimate fracture of the device.

• Brand Name: EQUINOXE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobsson ; 3523771140
• MDR Report Key: 15504813
• Report Number: 1038671-2022-01145
• Device Sequence Number: 5212123
• Product Code: LXH
• UDI-Device Identifier: 10885862087584
• UDI-Public: 10885862087584
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: EQUINOXE REVERSE SHOULDER DRILL KIT
• Device Catalogue Number: 321-20-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 12/15/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male