NA 324.024Recalls & reported problems
Synthes GmbH · PUSH-PULL REDUCTION DEVICE · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982190963), received between Feb 27, 2018 and Mar 27, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT IN QUESTION BROKE DURING SURGERY. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOMES ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PUSH-PULL REDUCTION DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18989668 ↗MalfunctionMay 28, 2021Break; Break
IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT (B)(6) SITE ON AN UNKNOWN DATE, THE PUSH-PULL REDUCTION SLEEVE WAS BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) PUSH-PULL REDUCTION DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11902238 ↗InjuryAug 27, 2018Break; Break
FURTHER, IT WAS REPORTED THAT THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 7820855 ↗MalfunctionFeb 27, 2018Break; Break
IT WAS REPORTED THAT DURING INITIAL OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR PROXIMAL HUMERUS, PUSH-PULL REDUCTION DEVICE BROKE INTO 2 PIECES. THERE WERE UNKNOWN MINUTES OF DELAY TO RETRIEVE FRAGMENTS FROM THE PATIENT'S BONE AND SWITCH TO NEW INSTRUMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7299300 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.