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

Catalog Number	531-78-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: SHOULDR GPS HEX PINS KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9181645
• Report Number: 1038671-2019-00507
• Device Sequence Number: 16993272
• Product Code: KWT
• UDI-Device Identifier: 10885862319197
• UDI-Public: 10885862319197
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 531-78-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention