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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgical use the surgeon impacted the poly which led to cracking of the 38 and 42 impactor tips, this also bent the impactor handle.When the surgeon was impacting definitive poly into the tray using the 38mm impactor tip (321-07-38), the tip impactor fractured.The surgeon impacted with the 42mm impactor tip (321-07-42) and the impactor was fractured and the handle bent (321-07-05).Event is not associated with a revision of exactech implants.Pieces had to be removed from the male patient's wound site.There was a 5-15 min surgical delay, no adverse events due to this prolongation.Patient was last known to be in stable condition following the event.Device to be returned.
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Additional Manufacturer Narrative
Section h10: (h3) based on historical complaint investigations and the returned devices, the fractured humeral liner impactor tips reported were 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 38M
• 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: 13825681
• Report Number: 1038671-2022-00269
• Device Sequence Number: 11878726
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 06/01/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male