ZUK 00578907100Recalls & reported problems
Smith & Nephew, Inc. · Tension Gauge · Class 1
All models of ZUK (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew ZUK tension gauge is a hand-held orthopedic surgical instrument used to check the tension of ligaments and soft tissue during joint surgery. The 35 reports describe the gauge breaking or cracking, sometimes during surgery and sometimes noticed before an operation; none report a death or injury. No recalls 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00885556618868), received between Feb 14, 2018 and Aug 16, 2021 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Break” (31 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 16, 2026.
Most reported problems
Device problems
- Break31
- Crack2
- Device Damaged by Another Device1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient10
- No Consequences Or Impact To Patient9
- No Information5
- Not Applicable1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2021Break; Break
IT WAS REPORTED THAT A ZUK TENSION GAUGE IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12325210 ↗MalfunctionAug 16, 2021Break; Break
IT WAS REPORTED THAT A ZUK TENSION GAUGE IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12325146 ↗MalfunctionJun 2, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING SET UP FOR A TKA, THE TENSION GAUGE WAS NOTICED TO BE CRACKED IN HALF. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11918398 ↗MalfunctionMay 27, 2021Break; Break
IT WAS REPORTED THAT TWO (2) GAP SPACERS BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED RELATIVE TO THE SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896195 ↗MalfunctionMay 27, 2021Break; Break
IT WAS REPORTED THAT TWO (2) GAP SPACERS BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED RELATIVE TO THE SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896062 ↗MalfunctionMay 13, 2021Break; Break
IT WAS REPORTED THAT, A TENSION GAUGE WAS BROKEN. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11822635 ↗MalfunctionMay 10, 2021Break; Break
IT WAS REPORTED THAT, DURING TKA, AN ARTICULAR SURFACE PROVISIONAL SZ 3 8MM, AN ARTICULAR SURFACE PROVISIONAL SZ 4 8MM AND A TENSION GAUGE, ALL THIS THREE ITEMS BROKE DURING SURGERY. INSTRUMENT OUTSIDE THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND IF THERE WAS DELAYED. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803023 ↗MalfunctionApr 27, 2021Break; Break
IT WAS REPORTED THAT DURING A FIELD INSPECTION, A TENSION GAUGE WAS NOTICED TO BE BROKEN. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11735026 ↗MalfunctionMar 19, 2021Break; Break
IT WAS REPORTED THAT, A TENSION GAUGE BROKE. INCIDENT OCCURRED DURING A UNICOMPARTMENTAL KNEE SURGERY WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11522613 ↗MalfunctionMar 14, 2021Crack; Crack
IT WAS REPORTED THAT DURING INSPECTION OF INSTRUMENTS, A CRACK WAS NOTICED IN TENSION GAUGE. NO CASE OR PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11478859 ↗MalfunctionMar 1, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE BROKEN AFTER PROCEDURE. PATIENT INJURIES WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11391234 ↗MalfunctionDec 31, 2020Crack; Crack
IT WAS REPORTED THAT THE END OF THE TENSION GAUGE WAS FOUND CRACKED. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11101221 ↗MalfunctionOct 2, 2020Break; Break
IT WAS REPORTED THAT DURING SURGERY, ITEM BROKE WHILE OUTSIDE THE PATIENT. PROCEDURE CONCLUDED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT A DELAY OR AN INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10618361 ↗MalfunctionAug 27, 2020Break; Break
IT WAS REPORTED THAT DURING SURGERY, ITEM BROKE WHILE OUT SIDE THE PATIENT. IT IS UNKNOWN IF PIECES FELL INSIDE THE PATIENT. NO DELAY AND NO INJURY REPORTED. PROCEDURE CONCLUDED WITH A BACK UP DEVICE FROM SMITH AND NEPHEW. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10460845 ↗MalfunctionAug 25, 2020Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY. EVENT OCCURRED DURING USE, WITH INSTRUMENTS OUTSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH A SN BACKUP DEVICE. NO DELAY WAS REPORTED. PATIENT INJURIES WERE NOT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10452273 ↗MalfunctionSep 17, 2019Break; Break
IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHILE THE SURGEON WAS USING THE TENSIONER GAUGE IT SNAPPED IN HALF. BOTH PIECES WERE RETRIEVED AND NOTHING WAS LEFT IN THE PATIENT. NO DELAY. NO CONFIRMATION OF BACKUP HAS BEEN RECEIVED. NO IMPACT OR INJURY TO PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9079835 ↗MalfunctionJun 24, 2019Break; Break
IT WAS REPORTED THAT DURING A TKA PROCEDURE ITEM CRACKED OVER THE INCISION OR WOUND IT WAS BEING USED TO CHECK TENSION. IT REMAINED IN ONE PIECE. NO PROCEDURAL DELAYS. NO INJURIES REPORTED. BACKUP DEVICE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8727640 ↗MalfunctionJun 3, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY, AMBER STICK BROKE DURING CASE WHILE CHECKING GAPS WITH TRIALS IN. NO DELAY. NO CONFIRMATION OF BACKUP HAS BEEN RECEIVED. NO IMPACT OR INJURY TO PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8663521 ↗MalfunctionApr 16, 2019Break; Break
IT WAS REPORTED THAT TENSION GAUGE BROKE DURING THE RANGE OF MOTION CHECK DURING THE CASE. ALL PIECES WERE RECOVERED. A BACKUP DEVICE WAS NOT NEEDED. NO DELAY OR INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8519571 ↗MalfunctionApr 15, 2019Break; Break
IT WAS REPORTED THAT DURING USE THE INSTRUMENT SNAPPED IN HALF WHEN THE DOCTOR ATTEMPTED TO INSERT IT INTO THE KNEE. NO DELAY OR INJURY REPORTED. A BACKUP DEVICE IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8512770 ↗MalfunctionJan 2, 2019Break; Break
IT WAS REPORTED THAT TENSION GAUGE SNAPPED IN HALF DURING TENSIONING PROCESS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8210428 ↗MalfunctionDec 26, 2018Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE GAP CHECKER BROKE. DELAY OF LESS THAN 30MIN REPORTED. NO INJURY OR BACK UP REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197921 ↗MalfunctionDec 14, 2018Break; Break
IT WAS REPORTED THAT THE TENSION GAUGE BROKE IN 4 PIECES DURING SURGERY (ALL PIECES RECOVERED), THE FLEXION GAP WAS TIGHT, SO THE SURGEON FORCE IT AND IT BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8164067 ↗MalfunctionNov 14, 2018Break; Break
IT WAS REPORTED THAT DURING SURGERY THE TENSION GAUGE BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8072224 ↗MalfunctionNov 2, 2018Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT A MALFUNCTION HAS OCCURREED. THE TENSION GAUGE BROKE DURING SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8033199 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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