MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; SHOULDER GPS REVERSE DRILL KIT

Catalog Number 531-20-00

Device Problem Material Disintegration (1177)

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

Event Date 06/27/2018

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.Device not available for evaluation.Engineering eval completed by ad on 16 oct 2018.The manufacturer of this drill bit, symmetry medical, has provided cytotoxicity testing for every paint color.Refer to ets-0229 and tm-2007-331 for details.Design-related issues: the design of the 3.2mm drill (531-15-07) that is part of the gps reverse drill kit (531-20-00) has been in the field since 2015.Exactech has received 3 similar complaint reports for cosmetic (paint chipping) issues involving 4 individual shoulder gps drill bits.This does not appear to be design related.Mfg-related issues: manufacturing data could not be reviewed because the manufacturing lot information was not provided.Corrective actions are not required because the occurrence rate is "very low" and the risk is captured in the rmr.The chipping paint reported in experience c2018-461 was likely the result of degradation of the epoxy paint over time due to normal use and processing.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.There is no reported patient adverse event.Bits of colored plastic were visible in the operating site; the surgeon removed all pieces.An investigation was conducted: the chipping paint reported was likely the result of degradation of the epoxy paint over time due to normal use and processing.

Event Description

It was reported from ous that during an orthopedic surgery the surgeon experienced an issue with the drill.During a gps case it was noticed that after drilling the holes for the glenoid compression locking screws - the reverse glenoid color-coded drill (3.2mm) was losing many of its colored bands.Bits of colored plastic were visible in the operating site.The surgeon removed all pieces.No further incident to the patient.Patient's health was stable leaving the or.This 3.2mm drill was part of a gps loan kit sent to the hospital just for this case.The agent was present at surgery.There was a delay to surgery with no patent adverse event.Device not returning.No additional information has been provided by the contacts related to this event following multiple attempts.

• Brand Name: EXACTECH
• Type of Device: SHOULDER GPS REVERSE DRILL KIT
• 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: 13451168
• MDR Text Key: 287582956
• Report Number: 1038671-2021-10076
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 531-20-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• 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