MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLEN BASEPLATE IMPACTOR

Catalog Number	321-19-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 321-19-13, 154685001 - glen baseplate impactor.
Event or Problem Description
As reported, the sterile processing staff member received the baseplate still attached to the handle.When attempting to separate the 2 pieces, the ball bearing securing the spring and locking mechanism of the baseplate has dropped out.This was done to wash the instruments.There was no patient involvement and the devices are returning.
Additional Manufacturer Narrative
Section h10: (h3) the most likely cause of the broken device reported is forcible separation of jammed instruments resulting in failure of the weld on the dowel pin.The underlying cause of the initial jam cannot be determined from the provided information and the other device involved in the incident was not returned for evaluation.Section h11: *the following sections have corrected information: (d2b) common device name: glen baseplate impactor (d4) catalog number: 321-19-13, lot number: 154685001, unique identifier (udi) #: (b)(4),(d10) concomitant medical products: 531-07-05, shldr gps impact handle.

• Brand Name: EQUINOXE
• Common Device Name: GLEN BASEPLATE IMPACTOR
• 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: 11371607
• Report Number: 1038671-2021-00069
• Device Sequence Number: 11447454
• Product Code: LXH
• UDI-Device Identifier: 10885862542038
• UDI-Public: 10885862542038
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 321-19-13
• Device Lot Number: 154685001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 11/15/2021
• 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