MAUDE Adverse Event Report: EXACTECH, INC. BH, STRT LOCK, BRCH POST; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number BH, STRT LOCK, BRCH POST

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the broach handle was being used in surgery and a piece broke off while in use.It did not affect the surgery, we just used the other broach handle.There were no pieces that fell into the patient.Patient was last known to be in stable condition following the event.Device will be returned.

Manufacturer Narrative

(h3) the evaluation noted that revision reported was likely the result of the actuation mechanism of the broach handle contains a lever and a sliding mechanism.The lever spring housing of each broach handle had fractured causing the mechanism to no longer actuate.Upon receipt the designs of the straight and curved broach handles were analyzed, and it was determined that the lever spring housing and lever actuator can contact each other in compression if the lever handle is closed without fully engaging the broach.These handles have similar internal mechanisms and are comparable to the other alteon broach handles.During testing the lever spring housing fractured in a similar way as the complaint product evaluation.After evaluating the component, improvements were proposed to make the design more robust.Additionally, device history records (dhr) for the lots associated with the complaint were reviewed and found to be acceptable with no indication of a manufacturing root cause.Use considerations were also assessed.If the lever handle is closed without fully engaging the broach, the lever spring housing will contact the lever actuator in compression.This can happen if the broach is not assembled correctly to the handle or if foreign debris such as bone fragments interfere with the broach fully seating itself.The most probable root cause of the lever spring housing fracture reported in was a combination of design and user misuse.However, a risk assessment has been initiated to escalate this issue.

• Brand Name: BH, STRT LOCK, BRCH POST
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11163333
• MDR Text Key: 226563447
• Report Number: 1038671-2021-00006
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862267122
• UDI-Public: 10885862267122
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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: BH, STRT LOCK, BRCH POST
• Device Catalogue Number: 01-003-02-0003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1