MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 309-10-25

Device Problem Break (1069)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation # and description: (b)(4), (b)(4), capa2020-15.Findings: per capa2020-15: 750-2010-031-dir-instruments design input-output matrix for humeral head reconstruction prosthesis instruments was reviewed to compile completed verifications and validations.The design control document had limited user needs, leading to design inputs that addressed functional and interface/compatibility requirements but had no specific performance requirements for the middle segment trials.The dhr was reviewed.The inspection results show that there were zero non-conformities identified during inspection, indicating that the reported events were not a result of a nonconformance identified during inspection of the devices.The devices are manufactured by bcs machine.The vendor documents were attached to the dhrs.The manufacturing documentation indicated that there were no non-conformities during the manufacture of the devices that would have resulted in the reported events.The root cause of the reported event was analyzed utilizing sop 701-103-742 and documented on form 701-104-796.Method was determined to be the primary root cause of the reported event with contributing factors of environment, material, and man, as explained in further detail below.Man: excessive force applied during the operative technique may cause stress on the device, which could result in failure (as reported in the event) material: material durability with regards to force applied and sterilization/reprocessing during lifetime of use for intended use environment: heats and pressures applied during repeated sterilization/disinfection may have contributed to material degradation over time.Most likely underlying cause/root cause: as determined by capa2020-15, the broken instrument reported in case-(b)(4) was likely the result of not considering specific performance requirements to capture user needs and design inputs (material durability during reprocessing/sterilization as well as force applied over lifetime of device), which led to insufficient testing to demonstrate continued performance over time and resulted in fracture during surgical use.Corrective action taken: action plan to address immediate issue will be handled under capa2020-15.Systemic issue(s) will be addressed under capa 2020-02.Capa2020-15 corrective actions: dir will be transferred to the new dtm form.Dtm will be revised to update user needs and design inputs in accordance with wi 701-105-187.Verification and validation activities will be updated as needed.General design review will be.

Event Description

It was reported from australia that instrument item #309-10-25 was returned from the hospital as damaged.The need for a replacement stock order was mentioned in the communication, in addition to a request to release the item based on the attached sas approval.It was also reported that during surgical use, upon removal of trial segment from stem insitu, the 4 ¿legs¿ of the trial broke.The pieces were retrieved from the wound site and accounted for.Relevant x-rays were unable to obtained.The patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17034785
• MDR Text Key: 316845365
• Report Number: 1038671-2023-01190
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309-10-25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Male