MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM

Model Number 320-20-38

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, the indication was a reverse shoulder for a primary surgery on this (b)(6) y/o patient.The surgeon noticed that the bone was very dense when he morcelled the cancellous bone to prepare the graft for the cage of the baseplate.When the surgeon drilled for the inferior screw (the first one), he asked for a green 4.5 compression screw.The surgeon told it was very hard to screw, and then changed the usual and appropriate equinoxe handle for the t-handle.The screw broke at the junction of the threaded part with the non-threaded part, just below the head.The part containing the head was thrown away.The screw was almost fully engaged in a way that the surgeon thinks that the part left in the patient cannot be seen on x-rays as a broken part of a screw.The cap was screwed as usual, with no difficulties.The choice was not confirmed by the use of the depth gauge.The agent reported that the color code of the drill was not damaged and still readable.The surgeon felt that the stability of the baseplate with 3 screws left in place on such a hard bone won¿t fail.No additional surgical time to report due to this incident.The devices were disposed of by the facility.

Manufacturer Narrative

Section h10: (a3) male.(h3) the broken screw reported in case: (b)(4) was likely the result of over torqueing the compression screw during use of the t-handle and the patient¿s reportedly hard and dense bone which led to fracture of the compression screw.However, this cannot be confirmed because the component was not returned for evaluation.Section h11: the following sections have corrected information: (b5) as reported, the indication was a reverse shoulder for a primary surgery on this 30 y/o, male patient.The surgeon noticed that the bone was very dense when he morcelled the cancellous bone to prepare the graft for the cage of the baseplate.When the surgeon drilled for the inferior screw (the first one), he asked for a green 4.5 compression screw.The surgeon told it was very hard to screw, and then changed the usual and appropriate equinoxe handle for the t-handle.The screw broke at the junction of the threaded part with the non-threaded part, just below the head.The part containing the head was thrown away.The screw was almost fully engaged in a way that the surgeon thinks that the part left in the patient cannot be seen on x-rays as a broken part of a screw.The cap was screwed as usual, with no difficulties.The choice was not confirmed by the use of the depth gauge.The agent reported that the color code of the drill was not damaged and still readable.The surgeon felt that the stability of the baseplate with 3 screws left in place on such a hard bone won't fail.No additional surgical time to report due to this incident.The devices were disposed of by the facility.Patient is doing well after surgery.

Event Description

As reported, the indication was a reverse shoulder for a primary surgery on this 30 y/o, male patient.The surgeon noticed that the bone was very dense when he morcelled the cancellous bone to prepare the graft for the cage of the baseplate.When the surgeon drilled for the inferior screw (the first one), he asked for a green 4.5 compression screw.The surgeon told it was very hard to screw, and then changed the usual and appropriate equinoxe handle for the t-handle.The screw broke at the junction of the threaded part with the non-threaded part, just below the head.The part containing the head was thrown away.The screw was almost fully engaged in a way that the surgeon thinks that the part left in the patient cannot be seen on x-rays as a broken part of a screw.The cap was screwed as usual, with no difficulties.The choice was not confirmed by the use of the depth gauge.The agent reported that the color code of the drill was not damaged and still readable.The surgeon felt that the stability of the baseplate with 3 screws left in place on such a hard bone won't fail.No additional surgical time to report due to this incident.The devices were disposed of by the facility.Patient is doing well after surgery.

• Brand Name: EQUINOXE
• Type of Device: REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11162707
• MDR Text Key: 226563693
• Report Number: 1038671-2021-00004
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086570
• UDI-Public: 10885862086570
• 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: 01/28/2021

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: Health Professional
• Device Model Number: 320-20-38
• Device Catalogue Number: 320-20-38
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR