VOLT 03.536.001Recalls & reported problems
Synthes GmbH · GUIDE BLOCK/ STANDARD FOR VOLT(TM) PROXIMAL HUMERUS PL · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982340740), received between Jan 6, 2026 and May 27, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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-Device Incompatibility2
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Entrapment of Device
IT WAS REPORTED ON AN UNKNOWN DATE THE PROXIMAL GUIDE BLOCK WAS LEFT IN THE PATIENT AND REMAINS INSIDE THE BODY. THE PATIENT CAME IN FOR 6 MONTHS FOLLOW UP WHERE THE SURGEON NOTICED AND CONTACTED THE REPORTER.
Patient problems: Foreign Body In Patient
MAUDE report 25300599 ↗MalfunctionJan 6, 2026Device-Device Incompatibility
IT WAS REPORTED ON AN (B)(6) 2025, THE SLEEVES DID NOT SLIDE FREELY EVEN WITH LUBRICATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980663 ↗MalfunctionJan 6, 2026Device-Device Incompatibility
IT WAS REPORTED ON AN (B)(6) 2025, THE SLEEVES DID NOT SLIDE FREELY EVEN WITH LUBRICATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980509 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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