MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM

Model Number 320-42-00

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 321-20-00, 5311621 - equinoxe reverse shoulder drill kit, 320-15-05, 5479862 - eq rev locking screw, 320-20-00, 5457241 - eq reverse torque defining screw kit, 320-10-00, 5411444 - equinoxe reverse tray adapter plate tray +0, 300-01-09, 5459262 - equinoxe, humeral stem primary, press fit 9mm, 320-01-42, 5462856 - equinoxe reverse 42mm glenosphere, 320-15-01, 5466552 - eq rev glenoid plate, 320-20-42, 4118750 - eq rev compress screw lck cap kit, 4.5 x 42mm.

Event Description

It was reported as suspected infection.Baseplate loosened and screw broke due to micro-motion.Surgeon left in the broken part of the screw because he couldn¿t get it out.There would be more damage retrieving it than leaving it.All implants removed from original case and put in a makeshift spacer.No adverse reaction to patient.

Manufacturer Narrative

Section h10: (a2) age at the time of event: 66 years, date of birth: (b)(6) 1952.(a3) patient sex: female.(h3) the revision reported was likely the result of the reported infection and an insufficient bond between implant and the bone, causing the baseplate to loosen.The loosening likely created ¿suspected micro-motion¿ as reported by the sales representative, and resulted in screw breakage.However, this cannot be confirmed as the device remains implanted; therefore, was not available for evaluation.(h6) evaluation codes: 1924, 1069.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported the patient¿s initial implant of the right shoulder was on (b)(6) 2018.The 67 y/o female is now revised on (b)(6) 2019 due to suspected infection.The baseplate was found to be loose and a screw was broken due to suspected micro-motion.The surgeon could not remove the screw due to suspicion of creating more damage trying to retrieve it.The screw was left in place and all other implants were replaced and a spacer was placed.Reportedly, there was no adverse reaction to patient.The specific screw left in place was not identified.Screw not returned due to remaining implanted.(d2) common device name: eq rev compress screw lck cap kit, 4.5 x 42mm.(d4) catalog number: 320-20-42, serial number: (b)(6), expiration date: 15-may-2022, unique identifier (udi) #: (b)(4).(h4) device manufacture date: 17-may-2017.No information provided in the following section(s): a4, a5, b6, b7, d6, d7, g8, h7, h9.

Event Description

As reported the patient¿s initial implant of the right shoulder was on (b)(6) 2018.The 67 y/o female is now revised on (b)(6) 2019 due to suspected infection.The baseplate was found to be loose and a screw was broken due to suspected micro-motion.The surgeon could not remove the screw due to suspicion of creating more damage trying to retrieve it.The screw was left in place and all other implants were replaced and a spacer was placed.Reportedly, there was no adverse reaction to patient.The specific screw left in place was not identified.Screw not returned due to remaining implanted.

• Brand Name: EQUINOXE
• Type of Device: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9207815
• MDR Text Key: 162873004
• Report Number: 1038671-2019-00525
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: 320-42-00
• Device Catalogue Number: 320-20-42
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR