Tornier Perform MWM054Recalls & reported problems
Tornier, Inc. · Humeral Head Impactor Tip · Class 1
Quick summary
This Tornier Perform humeral head impactor tip is used to seat the shoulder ball implant during surgery. The 52 reports all describe the metal tip fracturing, cracking or shattering during impaction, sometimes leaving fragments in the surgical field and in one case breaking after the seventh impact. No deaths or injuries were reported, and there are no recalls naming 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
- 50
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00846832082964), received between Jun 22, 2022 and Jul 15, 2026 — classified as 50 malfunctions.
The most frequently reported specific device problem is “Fracture” (43 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
- Fracture43
- Break36
- Crack10
- Material Fragmentation6
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25829139 ↗MalfunctionJul 7, 2026Fracture
MalfunctionJul 6, 2026Fracture
PRODUCT IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25721812 ↗MalfunctionNov 24, 2025Fracture; Fracture
IT WAS REPORTED THAT ON THE 7TH IMPACT IT JUST BROKE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23638942 ↗MalfunctionOct 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE DURING IMPACTION OF THE GLENOSPHERE DURING A PRIMARY SURGERY. DEBRIS WAS REMOVED FROM THE FIELD, THE GLENOSPHERE DIDN'T NEED ANY MORE IMPACTION. SURGERY CONTINUED AFTER LOOKING AT THE GLENOSPHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401609 ↗MalfunctionOct 8, 2025Fracture; Fracture
IMPACTOR TIP BROKE INTO TWO PIECES DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23245306 ↗MalfunctionSep 11, 2025Break; Fracture; Break; Fracture
BROKEN IMPACTOR TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23028249 ↗MalfunctionSep 10, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT BOTH INSTRUMENTS DID NOT PERFORM DUE TO BREAKING FROM USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23020490 ↗MalfunctionAug 27, 2025Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP WAS FOUND BROKEN IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909483 ↗MalfunctionAug 14, 2025Crack; Crack
HEAD IMPACTION TIP WAS CRACKED DURING IMPACTION IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805350 ↗MalfunctionAug 14, 2025Break; Fracture; Break; Fracture
THE GLENOSPHERE IMPACTOR TIP WAS DAMAGED DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805310 ↗MalfunctionAug 12, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THERE WAS A BREAKAGE DURING THE CASE AND A BACK UP WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784870 ↗MalfunctionJul 10, 2025Crack; Crack
IT WAS REPORTED THAT THE IMPACTOR TIP FROM PERFORM HUMERAL CORE TRAY CRACKED WHILE IMPACTING THE GLENOSPHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469800 ↗MalfunctionJun 18, 2025Break; Fracture; Break; Fracture
THE HEAD IMPACTOR TIP BROKE WHILE IMPACTING DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288108 ↗MalfunctionMay 8, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE INTRA-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21989022 ↗MalfunctionApr 30, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE DURING THE INSTALLATION OF THE GLENOSPHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936760 ↗MalfunctionApr 28, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE WHITE HUMERAL HEAD IMPACTOR TIP BROKE DURING IMPACTION OF GLENOSPHERE DURING CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21922302 ↗MalfunctionMar 28, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT IMPACTOR TIP WAS BROKEN DURING MED. PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21726603 ↗MalfunctionMar 19, 2025Break; Fracture; Break; Fracture
AS REPORTED: "IMPACTION TIP BROKE DURING CASE WHILE IMPACTING WITH A MALLET. ALL PIECES WERE EXTRACTED"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21647441 ↗MalfunctionMar 19, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642219 ↗MalfunctionMar 17, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING SURGERY BOTH IMPACTOR TIPS BROKE DURING IMPACTION. ALL DEBRIS WAS REMOVED FROM THE SURGICAL FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21626165 ↗MalfunctionMar 14, 2025Crack; Crack
IT WAS REPORTED THAT THE PEG BROKE OFF OF THE TRIAL AND THE IMPACTOR TIP BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21610769 ↗MalfunctionFeb 6, 2025Break; Fracture; Break; Fracture
THE GLENOSPHERE WAS BROKEN AFTER IT WAS STRUCK. IT WAS REPORTED THAT: "THE DEFECT WAS ONLY NOTICED AFTER THE PROCEDURE.".
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21328207 ↗MalfunctionJan 27, 2025Break; Crack; Fracture; Break; Crack; Fracture
IT WAS REPORTED THAT DURING A PRIMARY SURGERY, THE IMPACTOR TIP BROKE OR CRACKED IN HALF WHILE IMPACTING THE SPHERE IMPLANT USING THE SPHERE IMPACTOR TIP. NO DEBRIS WAS REPORTED, AS THE DEVICE BROKE INTO TWO PIECES, WHICH WERE REMOVED FROM THE FIELD. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A DIFFERENT IMPACTOR TIP. THE REPORTER STATED THAT THEY TAPPED THE SCREWDRIVER TO ENGAGE SCREW OF SPHERE AND THAT ALSO HELPED/WORKED. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION BY THE MANUFACTURER, AS IT WAS REPORTED TO BE LOST. IT WAS APPROXIMATED THAT THE DEVICE HAS BEEN IN SERVICE FOR 2-3 YEARS, AND HAS BEEN USED AND REPROCESSED OVER 100 TIMES. THE DEVICE WAS INSPECTED PRIOR TO BEING SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21247654 ↗MalfunctionJan 3, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING A PERFORM GLENOSPHERE USING THE PERFORM HUMERAL IMPACTOR TIP FROM THE PERFORM HUMERAL CORE TRAY. DURING THE PROCEDURE, THE PLASTIC TIP OF THE IMPACTOR SPLIT IN TWO AFTER ONE STRIKE WITH A MALLET. ONE HALF STAYED IN THE JOINT, AND THE OTHER REMAINED THREADED INTO THE IMPACTOR HANDLE. BOTH PIECES WERE PROMPTLY RETRIEVED, INSPECTED, AND ACCOUNTED FOR, ENSURING NO FRAGMENTS WERE LEFT IN THE SURGICAL SITE. THE SURGERY CONTINUED WITHOUT DELAY USING AN ALTERNATE IMPACTOR TIP FROM THE PERFORM PMI TRAY, AND THE SPHERE LOCKING SCREW WAS SECURED PER TECHNIQUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067827 ↗
Other IMPACTOR devices
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- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.