NA 03.037.016Recalls & reported problems
Synthes GmbH · BUTTRESS/COMPRESSION NUT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes buttress compression nut, a surgical instrument, has 201 adverse event reports, with no deaths and 3 injuries. Most reports describe threads that have worn, stripped or cross-threaded, parts that do not fit together during surgery, and bent instrument parts. There are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 203
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 10886982070326), received between Dec 21, 2016 and Sep 29, 2026 — classified as 3 injuries, 200 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (118 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility118
- Material Twisted/Bent67
- Mechanical Jam15
- Material Integrity Problem11
- Break8
- Device Slipped7
- Material Deformation4
- Sticking3
Patient problems
- No Clinical Signs, Symptoms or Conditions144
- No Consequences Or Impact To Patient20
- No Patient Involvement16
- No Known Impact Or Consequence To Patient15
- Insufficient Information7
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 25 most recent of 203 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Corroded; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933086 ↗MalfunctionSep 9, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50697996 ↗MalfunctionAug 26, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459911 ↗MalfunctionAug 26, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459885 ↗MalfunctionApr 9, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829601 ↗MalfunctionApr 3, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE, THE ITEMS JAMMED TOGETHER. IT APPEARS THAT THEY HAVE BECOME CROSS THREAD INTRA-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780690 ↗MalfunctionMar 13, 2026Mechanical Jam
IT WAS REPORTED THAT DURING PRE-OPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE BUTTRESS/COMPRESSION-NUT IS STUCK ON THE SLEEVE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597805 ↗MalfunctionMar 3, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TFNA BUTTRESS COMPRESSION NUTS AND BLADE GUIDE SLEEVES ARE STRIPPED/CROSS THREADED DUE TO WEAR AND TEAR OVER TIME AND ARE NO LONGER OPERATIONAL. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500431 ↗MalfunctionMar 3, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TFNA BUTTRESS COMPRESSION NUTS AND BLADE GUIDE SLEEVES ARE STRIPPED/CROSS THREADED DUE TO WEAR AND TEAR OVER TIME AND ARE NO LONGER OPERATIONAL. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500428 ↗MalfunctionMar 3, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TFNA BUTTRESS COMPRESSION NUTS AND BLADE GUIDE SLEEVES ARE STRIPPED/CROSS THREADED DUE TO WEAR AND TEAR OVER TIME AND ARE NO LONGER OPERATIONAL. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500427 ↗MalfunctionFeb 24, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED REPROCESSING STAFF NOTICED THAT SEVERAL INSTRUMENTS ARE ALL STRIPPED AND NO LONGER FIT TOGETHER IN ORDER TO ACHIEVE COMPRESSION OF THE NAIL/FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429887 ↗MalfunctionFeb 24, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED REPROCESSING STAFF NOTICED THAT SEVERAL INSTRUMENTS ARE ALL STRIPPED AND NO LONGER FIT TOGETHER IN ORDER TO ACHIEVE COMPRESSION OF THE NAIL/FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429882 ↗MalfunctionFeb 24, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED REPROCESSING STAFF NOTICED THAT SEVERAL INSTRUMENTS ARE ALL STRIPPED AND NO LONGER FIT TOGETHER IN ORDER TO ACHIEVE COMPRESSION OF THE NAIL/FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429822 ↗MalfunctionFeb 17, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON 02 FEBRUARY, 2026 UPON DISENGAGING TFNA LAG SCREW DRILL/INSERT SLEEVE, THE OUTER SLEEVE AND BUTTRESS WHEEL WOULD NOT DISENGAGE. SURGEON AND SCRUB TECH USED A MALLET TO RELEASE IT AND CAUSED THE BUTTRESS WHEEL TO CROSS THREAD WITH THE OUTER SLEEVE. SURGERY WAS DELAYED FOR 5 MINUTES DUE TO THE REPORTED EVENT. MALLETED SLEEVE AND WHEEL OUT, PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369908 ↗MalfunctionFeb 10, 2026Material Integrity Problem; Material Twisted/Bent
IT WAS REPORTED THAT UPON INSPECTION ITEMS IN TFNA SETS SHOW TO BE WORN/DAMAGED AND NEED TO BE REPLACED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302933 ↗MalfunctionFeb 6, 2026Material Integrity Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING INSPECTION OF TFNA SETS, IT WAS IDENTIFIED THAT THE DEVICE IS WORN OR DAMAGED AND REQUIRE REPLACEMENT. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT, AND NO SIGNIFICANT DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280676 ↗MalfunctionFeb 6, 2026Material Integrity Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING INSPECTION OF TFNA SETS, IT WAS IDENTIFIED THAT THE DEVICE IS WORN OR DAMAGED AND REQUIRE REPLACEMENT. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT, AND NO SIGNIFICANT DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280674 ↗MalfunctionFeb 6, 2026Material Integrity Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING INSPECTION OF TFNA SETS, IT WAS IDENTIFIED THAT THE DEVICE IS WORN OR DAMAGED AND REQUIRE REPLACEMENT. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT, AND NO SIGNIFICANT DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280669 ↗MalfunctionFeb 6, 2026Material Integrity Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING INSPECTION OF TFNA SETS, IT WAS IDENTIFIED THAT THE DEVICE IS WORN OR DAMAGED AND REQUIRE REPLACEMENT. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT, AND NO SIGNIFICANT DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280667 ↗MalfunctionFeb 6, 2026Material Integrity Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING INSPECTION OF TFNA SETS, IT WAS IDENTIFIED THAT THE DEVICE IS WORN OR DAMAGED AND REQUIRE REPLACEMENT. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT, AND NO SIGNIFICANT DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280663 ↗MalfunctionFeb 5, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE GUIDE WIRE MISSED THE NAIL HOLE FOR HELICAL BLADE. SURGERY WAS DELAYED FOR FORTY (40) MINUTES DUE TO THE REPORTED EVENT. THE NAIL WAS REMOVED AND REINSERTED USING SECOND SET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273311 ↗MalfunctionJan 23, 2026Device-Device Incompatibility
IT WAS REPORTED DURING A TFNA, THE HELICAL BLADE OR TRIPLE TROCAR HAS BEEN CATCHING. WE WEREN¿T ABLE TO GET THE HELICAL BLADE INSERTED/TROCAR OUT OF THE AIMING ARM/COMPRESSION NUT. NOT SURE WHICH PART WAS THE ISSUE. NO PATIENT HARM. SURGICAL DELAY OF 5-10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24161836 ↗MalfunctionJan 21, 2026Device-Device Incompatibility
IT WAS REPORTED THE COMPRESSION NUT IS STUCK OVER THE GUIDE SLEEVE. IT CAN NO LONGER SPIN FREELY. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24128664 ↗MalfunctionDec 16, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE THE INSTRUMENTS WOULD NOT STAY ENGAGED TOGETHER WHILE INSERTING THE HEAD ELEMENT. THE ISSUE WAS EVENTUALLY RESOLVED BY CAREFULLY AVOIDING PRESSURE TO KEEP THE DEVICES CLICKED TOGETHER. THERE WAS NO DELAY IN SURGERY AND NO PATIENT CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822312 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE BUTTRESS NUT WAS CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708324 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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