MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RETROVERSION HNDL

Catalog Number	301-03-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(device evaluated by manufacturer) pending evaluation.Concomitant device(s): 301-07-10, 158157004 - prm stm insrtr extrct.*no information provided in the following section(s): date of birth, sex, weight, ethnicity, relevant tests, other relevant history, implant date, explant date, pma/510(k), manufacturer report number, device manufacture date, recall, correction/removal report number.
Event or Problem Description
As reported, when inspecting the kit on its return from a customer, it was noticed that part # 301-03-10 had been placed in a bag with a note saying it was broken from cssd at (b)(6).On closer inspection it was noticed that part # 301-07-10 was also damaged and had the broken bit from part # 301-03-10 still stuck in the handle.The customer was unable to give an explanation as to when and how it broke.Devices to be returned.It is unknown if a patient was involved or if the break happened while cleaning.
Additional Manufacturer Narrative
(h3) based on historical complaint investigations and the reported event, the broken retroversion handle reported may have been the result of impacting the junction between the primary stem inserter/extractor and retroversion handle, allowing for the applied force to be transmitted to the threaded tip of the retroversion handle, leading to ultimate failure.However, this cannot be confirmed as the customer was unable to give an explanation as to when and how the device broke.Section h11: *the following sections have corrected information: (h6) health effect - clinical code: 4582.
Additional Manufacturer Narrative
Section h10: (h3) updated due to device being returned.Based on historical complaint investigations, the returned devices, and the reported event, the broken retroversion handle reported may have the result of impacting the junction between the primary stem inserter/extractor and retroversion handle, allowing for the applied force to be transmitted to the threaded tip of the retroversion handle, leading to ultimate failure.However, this cannot be confirmed as the customer was unable to give an explanation as to when and how the device broke.

• Brand Name: EQUINOXE
• Common Device Name: RETROVERSION HNDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11076071
• Report Number: 1038671-2020-00667
• Device Sequence Number: 2586406
• Product Code: LXH
• UDI-Device Identifier: 10885862079626
• UDI-Public: 10885862079626
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 07/20/2021

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: 301-03-10
• Device Lot Number: 70725001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 04/13/2021; 06/30/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 04/20/2021; 07/20/2021
• 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