MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDR GPS HEX PINS KIT

Catalog Number 531-78-20

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 05/16/2019

Event Type  Injury  

Event Description

It was reported that the surgeon placed hex pins in the coracoid to fix the coracoid block to the coracoid.The surgeon was aware that this patient had poor bone.During the glenoid registration, the patient¿s coracoid broke.The coracoid block and tracker could not be reattached since there was insufficient coracoid bone left.We continued on with the reverse shoulder without gps and the case went well.

Event Description

During a tsa procedure, the surgeon placed hex pins in the coracoid to fix the coracoid block to the coracoid.The surgeon was aware that this patient had poor bone quality.During the glenoid registration, the patient's coracoid broke.The coracoid block and tracker could not be reattached since there was insufficient coracoid bone left.The procedure continued with the reverse shoulder without gps and the case went well.

Manufacturer Narrative

Section h10: (h3) during a tsa procedure, the surgeon placed hex pins in the coracoid to fix the coracoid block to the coracoid.The surgeon was aware that this patient had poor bone quality.During the glenoid registration, the patient's coracoid broke.The coracoid block and tracker could not be reattached since there was insufficient coracoid bone left.The procedure continued on with the reverse shoulder without gps and the case went well.A known surgical risk for total joint revision is potential bone fracture.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.The most likely cause for the bone fracture was the patient conditions.(h6) evaluation codes: 1870, 2993.Section h11: *the following sections have corrected information: (b5) during a tsa procedure, the surgeon placed hex pins in the coracoid to fix the coracoid block to the coracoid.The surgeon was aware that this patient had poor bone quality.During the glenoid registration, the patient's coracoid broke.The coracoid block and tracker could not be reattached since there was insufficient coracoid bone left.The procedure continued with the reverse shoulder without gps and the case went well.

• Brand Name: EQUINOXE
• Type of Device: SHOULDR GPS HEX PINS KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9181645
• MDR Text Key: 164574391
• Report Number: 1038671-2019-00507
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862319197
• UDI-Public: 10885862319197
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 531-78-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention