MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 3.2MM K-WIRE, THREADED

Model Number	321-52-08
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 315-52-66, 292002003 - mod cannulated drill cage, small reverse.
Event or Problem Description
It was reported that during surgical use the k-wire was in the glenoid and when it was time to use the mini baseplate drill to drill the center cage, the k-wire tip started to break apart.The tip was then stuck in the drill.Both devices were removed and new ones were used to complete the case.No patient information or medical history reported.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the broken device reported may have been the result of the k-wire binding with the drill bit while the drill was under power which led to the reported wire fracture.However, this cannot be confirmed since the wire was not returned for evaluation.Section h11: *the following sections have corrected information: (h6) component code: 3123, tip.

• Brand Name: EQUINOXE
• Common Device Name: 3.2MM K-WIRE, THREADED
• 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: 13190297
• Report Number: 1038671-2022-00016
• Device Sequence Number: 4315627
• Product Code: LXH
• UDI-Device Identifier: 10885862580757
• UDI-Public: 10885862580757
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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 Model Number: 321-52-08
• Device Catalogue Number: 321-52-08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown