MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TRULIANT TIB TAMP GUIDE

Catalog Number 02-029-22-2000

Device Problem Separation Problem (4043)

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

Event Date 01/14/2020

Event Type  malfunction  

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.Findings: according to the experience report, ¿blue button on device was missing during surgery.Instrument was used by holding tibial broach by hand during impaction.Broach was removed with pliers after impaction.Broken instrument will be retrieved and returned.No parts left in wound site.¿ engineering prints of 02-029-122-2000 were reviewed.The overlap between the snap ring¿s od and the id of the housing lip is.008 for the worst-case scenario.Although the overlap is positive, the small amount could cause disengagement.Corrective action taken: per crc2018-08-31-02, the committee determined that the design would be updated, tested, and implemented, after which a staged market withdrawal was conducted.Per capa2018-35: 1.A stock audit was performed for the devices located in 01 (coc).See npr-40446 and npr-45222 for details.Defective devices were dispositioned for rework.2.The design was updated to increase the overlap of the snap ring and the housing lip components.See dcrtc-18-0401 and dcrtc-19-0446 for details.3.The defected devices returned from the field are to be reworked.See staged market withdrawal of truliant tibial tamp guide documented in the capa for details.Most likely underlying cause/root cause: per capa2018-35, the root cause for the button disengagement reported was likely the result of insufficient overlap between the snap ring and the lip of the housing to prevent the occurrence of disengagement.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: (1) appropriate reading of the literature, and (2) training in the operative skills and techniques required for surgery, and (3) 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.There was no reported patient adverse event due to the missing button on the instrument, nothing was left in the patient.Per capa2018-35, the root cause for the button disengagement reported was likely the result of insufficient overlap between the snap ring and the lip of the housing to prevent the occurrence of disengagement.

Event Description

It was reported from the us that during an orthopedic surgery there was a disassembly of an instrument.The blue button on the device was missing during surgery.The instrument was used by holding the tibial broach by hand during impaction.The surgeon was able to use the instrument in the nonfunctional state.The surgery nor patient compromised by the event.The broach was removed with pliers after impaction.No parts left in wound site.There was no reported patient adverse event.No information on the overall patient outcome or patient demographics.Multiple email requests were sent to the contacts for additional information.No additional information was provided by the contacts related to this event.

• Brand Name: EXACTECH
• Type of Device: TRULIANT TIB TAMP GUIDE
• 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: 13998985
• MDR Text Key: 298281167
• Report Number: 1038671-2022-00363
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02-029-22-2000
• Device Lot Number: 105600006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/14/2020
• Date Manufacturer Received: 01/14/2020
• 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: Unknown
• Patient Sequence Number: 1