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

Catalog Number	315-25-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use, the instrument broke; the pilot nose sheared off.Surgeon confident of clean break and both pieces retained, no patient impact.The surgeon checked for parts and pieces.No patient information reported.
Additional Manufacturer Narrative
Section h10: (d4) lot number: 53636003 (h3) based on historical complaint investigations and the returned device, the broken reamer reported in was likely the result of the reamer experiencing high loads possibly during off-axis reaming and/or coming in contact with hard bone, which led to brittle fracture.

• Brand Name: EQUINOXE
• Common Device Name: MDLR PRM RMR MD PLT TIP
• 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: 13003329
• Report Number: 1038671-2021-00695
• Device Sequence Number: 17305001
• Product Code: LXH
• UDI-Device Identifier: 10885862085351
• UDI-Public: 10885862085351
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (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): 01/25/2022

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 Catalogue Number: 315-25-13
• Device Lot Number: 53636003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/25/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown