MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE TORQUE DEFINING SCREW SQUARE DRIVE KIT; SCREW KIT

Catalog Number 300-20-02

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Joint Disorder (2373)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision due to loosening.

Manufacturer Narrative

Section h3: all patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Patients must be informed that their weight and activity level may affect the longevity of the implant.Patients should be advised to report any pain, decrease in range of motion, swelling, fever, or unusual sounds as this may indicate positional changes in the implant that could lead to premature failure.Upon review of all available information, the "revision due to loosening" was likely the result of an insufficient bond between the implant and bone, which led to the aseptic (non-infected) loosening.However, this cannot be confirmed because the devices were not available for evaluation, and adequate information has not been provided.This device is used for treatment not diagnosis.No information, asked not provided.

Event Description

It was reported that a 62 y/o female patient had a revision of shoulder components due to loosening approximately 18 months after the initial implantation.No other information was reported.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00342, 1038671-2018-00343, 1038671-2018-00344, 1038671-2018-00345 and 1038671-2018-00346.

• Brand Name: EQUINOXE TORQUE DEFINING SCREW SQUARE DRIVE KIT
• Type of Device: SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7464223
• MDR Text Key: 106601161
• Report Number: 1038671-2018-00344
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/13/2020
• Device Catalogue Number: 300-20-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR