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

Model Number	321-07-42
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that surgeon impacted humeral liner, device developed a crack.Part didn't actually break, rather cracked, so no pieces came loose.No parts fell into the(b)(6) patient's wound.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) based on historical complaint investigations and the returned device, the cracked humeral liner impactor tip reported was likely the result of a stress riser introduced during impaction, which led to crack initiation and propagation.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.Section h11: the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• 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: 14237642
• Report Number: 1038671-2022-00481
• Device Sequence Number: 17228017
• Product Code: LXH
• UDI-Device Identifier: 10885862087188
• UDI-Public: 10885862087188
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 08/31/2022

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 Model Number: 321-07-42
• Device Catalogue Number: 321-07-42
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male