MAUDE Adverse Event Report: EXACTECH, INC. STANDARD GPS CENTER DRL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	531-55-64
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement procedure.After using navigation to locate the starting point for drilling the patient's bone for placement of the glenoid cage component, it was noted that the patient's glenoid bone fractured.The fracture was treated by filling the space with bone graft and the surgeon drilled a new hole for placement of the cage to complete the procedure.Following placement, it was noted that the implant may have been placed a little higher than preferred.It is unknown how the patient is doing post-op.

• Brand Name: STANDARD GPS CENTER DRL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21235873
• Report Number: 1038671-2025-00414
• Device Sequence Number: 9059402
• Product Code: OLO
• UDI-Device Identifier: 10885862583185
• UDI-Public: 10885862583185
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 531-55-64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female