GPS 531-01-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862527769), received between Oct 11, 2019 and Sep 21, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K162567, K173372); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE CLINICAL DATA STUDY BASE, A (B)(6) Y/O FEMALE PATIENT PRESENTED FOR A 6-WEEK POSTOP L TSA EXAM AND A CORACOID FRACTURE WAS NOTED. THERE WAS NO ADDITIONAL TREATMENT FOR THE FRACTURE. IT IS UNKNOWN WHEN THE FRACTURE OCCURRED, HOWEVER, THE AE REPORT FROM THE STUDY STATES ¿POST-OP¿. THE PATIENT HAS A HISTORY OF OSTEOARTHRITIS AND HYPERTENSION. IT IS NOTED THAT AUTOGRAFT WAS USED BEHIND THE BASEPLATE DURING THE PROCEDURE AND GPS NAVIGATION WAS ALSO USED DURING THE PROCEDURE. PATIENT OUTCOME WAS NOTED AS ¿CONTINUING¿. THERE ARE NO DEVICES TO BE RETURNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10559589 ↗
• InjuryOct 11, 2019Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9181579 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162567, K173372. One submission often covers many models, so check the product and lot details in each record.

• Z-2050-2023 · Jun 5, 2023 · Open, Classified
  Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
• Z-0603-2018 · Jul 11, 2017 · Terminated
  Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool