MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUM HD IMPCTR

Catalog Number	311-07-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 301-03-01, mdlr broach hndl.13 + replicator 1.5 stem.
Event or Problem Description
As reported, during a shoulder procedure on a 30 y/o male, the final stem 13 + replicator 1.5 were mounted together on a back table assembly.The humeral head, short, 47mm was impacted as well on the back table.This construct was then impacted in the humerus, the stem was stuck 2 cm higher than the cut.During the impaction, the humeral head impactor tip was broken.A femoral head impactor present in the hospital has been consequently used to go on the surgery.Patient was last known to be in stable condition following the event.Devices are to be returned.
Additional Manufacturer Narrative
Section h10: (h3) based on previous complaint investigations, the broken impactor handle reported in (b)(4) was likely the result of not fully securing the impactor handle to a mating tip, and then impacting off-axis, which led to crack initiation, propagation, and ultimate fracture of the threads on the handle.

• Brand Name: EQUINOXE
• Common Device Name: HUM HD IMPCTR
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10841089
• Report Number: 1038671-2020-00614
• Device Sequence Number: 3526223
• Product Code: LXH
• UDI-Device Identifier: 10885862084316
• UDI-Public: 10885862084316
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 311-07-05
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 11/14/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 30 YR