MAUDE Adverse Event Report: EXACTECH, INC. GPS SHOULDER APPLICATION SHOULDER GPS APP; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GPS SHOULDER APPLICATION SHOULDER GPS APP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

H6: the initial technical review indicated, "first, the cage hole navigation was done really close to the posterior part of the vault.Then, during the screw navigation step, the posterior inferior screw drilled hole seems to have pierce the vault several times.Finally, the superior screw drilled hole seems to have pierced the anterior part of the vault.For sake of clarification, the slice views and the screw position were displayed by the gps system during the protocol.¿ this manufacturer's devices were used during this procedure, however; there were no allegations against the devices.The surgeon is observing the patient.So far, he has not had to repair anything.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.Due to evaluation of the navigation case review, the cause of "vault fracture during the surgical revision, is most likely related to user error.These devices are used for treatment not diagnosis.

Event Description

It was reported that following a shoulder implant procedure, the surgeon reached out indicating ¿something isn¿t right on the x-ray.I think it¿s a vault fracture, ct says no.¿ the surgeon wanted some additional information and technical analysis as he thinks he may have fractured the vault.The surgeon was wanting to see the final placement of the implant and if that matches with the post op x-ray.

• Brand Name: GPS SHOULDER APPLICATION SHOULDER GPS APP
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17134515
• MDR Text Key: 317222769
• Report Number: 1038671-2023-01355
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GPS SHOULDER APPLICATION SHOULDER GPS APP
• Device Catalogue Number: L00040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other