MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUM LNR IMPACT TIP 42M

Catalog Number	321-07-42
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that during impaction, the resident impacted the humeral liner trial into the humeral adapter tray to get it seated, utilizing a 42mm humeral liner impactor tip.Upon impaction, the top of the impactor tip fracted off.There was no surgical delay.Patient was last known to be in stable condition following the event.Device to be returned.
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that during impaction, the resident impacted the humeral liner trial into the humeral adapter tray to get it seated, utilizing a 42mm humeral liner impactor tip.Upon impaction, the top of the impactor tip fracted off.There was no surgical delay.Patient was last known to be in stable condition following the event.Device to be returned.
Additional Manufacturer Narrative
(h3) based on historical complaint investigations and the returned device, the fractured humeral liner impactor tip reported was likely the result of a stress riser introduced during impaction, which led to crack initiation, propagation, and ultimate fracture.Additionally, the devices 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 42M
• 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: 13581237
• Report Number: 1038671-2022-00218
• Device Sequence Number: 17245815
• Product Code: LXH
• UDI-Device Identifier: 10885862087188
• UDI-Public: 10885862087188
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 03/22/2022

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: 321-07-42
• Device Lot Number: 144217028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/23/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown