MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUM LNR IMPACT TIP 38M

Catalog Number	321-07-38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, whilst impacting the definitive liner in for a shoulder replacement, the liner impactor head cracked into pieces.All pieces were removed from the patient.The patient was last known to be in stable condition following the event.Patient was not harmed.Device to be returned.
Additional Manufacturer Narrative
(h3) based on previous similar complaint investigation, the fractured humeral liner impactor tip reported in experience(b)(4) was likely the result of a stress riser introduced during impaction, which led to crack initiation, propagation, and ultimate fracture.Additionally, the device may have experienced material degradation if sterilized beyond the recommended parameters listed in the reprocessing instruction which could have led to the observed failure.

• Brand Name: EQUINOXE
• Common Device Name: HUM LNR IMPACT TIP 38M
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10559612
• Report Number: 1038671-2020-00529
• Device Sequence Number: 2627582
• Product Code: LXH
• UDI-Device Identifier: 10885862087171
• UDI-Public: 10885862087171
• 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
• Report Date (Section B): 11/14/2020

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 Catalogue Number: 321-07-38
• Device Lot Number: 259377036
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR