MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; REAMER STARTER, MODULAR REVERSE, PILOT TIP

Catalog Number 321-25-01

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, fei (b)(4), has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.The device was received for analysis.Other than the broken reamer tip, all other aspects of the instrument appear to be unremarkable.Design: this device design has been in the field since 2009.At this time of the engineering analysis on 30 jul 2017, exactech had received 25 similar complaints of tip breakage involving 27 individual devices with an approximate complaint occurrence rate of (b)(4).This rate is "very low" and was address in capa (b)(4) with the operative guide updated to include a warning regarding off-axis reaming.Manufacturing: no other complaints had been received involving this lot, containing (b)(4) units.This lot has been in the field since 2015; therefore, this issue does not seem to be related to any manufacturing - related cause.Most likely cause: an investigation was conducted that the most likely root cause of the device breakage reported in this event was likely due to off-axis reaming, allowing excessive torque on the tip of the device which lead to the breakage.Ifu 700-096-181: instrument inspection · visually inspect the instruments for damage such as fractures; cracks; gouges; deformation; burrs; discoloration, corrosion, or rust; excessive component wear; nicks on cutting surfaces, missing or loose components; blockages in cannulae, cleaning holes or other cavities that cannot be removed via standard cleaning; worn or difficult to read markings/engravings; or other apparent damage.· check the function of mechanisms by actuating any levers, knobs, switches, connectors, sliding features, hinges, or other mechanical interface features.Ensure smooth operation of these features over their functional range of motion.· if damage, wear, or non-functioning/poorly functioning mechanisms are found, do not use the instrument, and contact the sales representative or customer service for disposition.Ifu states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: appropriate reading of the literature, and training in the operative skills and techniques required for surgery, and reviewing information regarding use of instrumentation.It is a clinical standard of practice in the operating room that all instruments should be visually and functionally inspected before use, these guidelines are from standard association of peri-operative registered nurses (aorn) guidelines.Surgeons are to be familiar and knowledgeable with all instrumentation, devices and proficient with surgical techniques.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues, nor did it lead to patient impact.An investigation was conducted; this event was likely due to off-axis reaming, allowing excessive torque on the tip of the device which lead to the device breakage.

Event Description

It was reported that the reamer tip was placed in the 2mm drill hole that was drilled for the reamer, flush against the glenoid and the reaming sequence started.As the reamer contacted the bone and reaming began, the torque of the reamer sheared off.We proceeded to a 38 reamer and finish reaming.The patient received a 38 glenosphere with great range of motion and function.

• Brand Name: EXACTECH
• Type of Device: REAMER STARTER, MODULAR REVERSE, PILOT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 13937982
• MDR Text Key: 288123965
• Report Number: 1038671-2022-10013
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-01
• Device Lot Number: 6806023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 82 KG