MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number HUM LNR IMPACT TIP 36MM

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  Injury  

Event Description

The center of the poly impactor broke while impacting the poly.There was a 30 seconds surgical delay which was enough time to switch to the 38mm impactor.No patient impact reported due to the delay.Patient was last known to be in stable condition following the event.The product was returned for analysis.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H6: based on historical complaint investigations, the image provided, and the reported event, 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 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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16667660
• MDR Text Key: 312555750
• Report Number: 1038671-2023-00568
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10885862558831
• UDI-Public: 10885862558831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

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
• Device Operator: Health Professional
• Device Model Number: HUM LNR IMPACT TIP 36MM
• Device Catalogue Number: 321-09-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female