1.5MM SYSTEM 50-1010Recalls & reported problems
Biomet Microfixation, Inc · Class 1
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00841036063504), received between Nov 16, 2021 and Jan 22, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (10 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping10
- Packaging Problem3
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING INSPECTION AT THE DISTRIBUTORSHIP, IT WAS FOUND THAT THE INNER PACKAGING HAD A HAIR-LIKE SUBSTANCE WITHIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24152457 ↗MalfunctionOct 3, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20363614 ↗MalfunctionMay 8, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16885325 ↗MalfunctionMay 8, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING INSPECTION AT THE RECEIVING WAREHOUSE, THERE WAS DEBRIS FOUND IN THE STERILE PACKAGING. NO CUSTOMER OR PATIENT WAS INVOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16884933 ↗MalfunctionMay 8, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16884929 ↗MalfunctionApr 6, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS DEBRIS INSIDE OF THE BATTERY PACKAGE. NO ADVERSE CONSEQUENCES HAVE RESULTED FROM THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16688843 ↗MalfunctionMar 28, 2023Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16628244 ↗MalfunctionJun 7, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE INNER PACKAGE IS DAMAGED. THE ISSUE WAS DISCOVERED DURING AN INCOMING PRODUCT INSPECTION. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14626067 ↗MalfunctionMar 28, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING AN INCOMING INSPECTION THAT FOREIGN MATERIAL WAS IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13934492 ↗MalfunctionNov 16, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING RECEIVING INSPECTION FOREIGN MATERIAL WAS DISCOVERED IN THE STERILE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12820080 ↗MalfunctionNov 16, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING RECEIVING INSPECTION FOREIGN MATERIAL WAS DISCOVERED IN THE STERILE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12820067 ↗MalfunctionNov 16, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12820056 ↗MalfunctionNov 16, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12820055 ↗
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- NA 530.710Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,800 reports
- NA 530.705Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,492 reports
- NA 530.715Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED390 reports
- NA 530.730Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED267 reports
- NA 05.001.240Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED262 reports
- KINCISE™ 1000-00-101Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED242 reports
- NA 530.791Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED84 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.