KINCISERecalls & reported problems across all models
Synthes GmbH · 16 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 417
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 16 models of KINCISE by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 417 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2020 and Sep 29, 2026 — classified as 2 injuries, 415 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported KINCISE problems
Device problems
- Material Fragmentation118
- Unintended System Motion97
- Complete Loss of Power79
- Physical Resistance/Sticking74
- Detachment of Device or Device Component73
- Appropriate Device Problem Term/Code Not Available44
- Device-Device Incompatibility36
- Device Slipped28
Patient problems
- No Clinical Signs, Symptoms or Conditions411
- No Consequences Or Impact To Patient3
- Limb Fracture2
- Foreign Body In Patient1
KINCISE models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- KINCISE™ 1000-00-101MOTOR, SURGICAL INSTRUMENT, AC-POWERED242 reports
- KINCISE™ 1011-01-101MOTOR, SURGICAL INSTRUMENT, AC-POWERED51 reports
- KINCISE™ 1013-00-901MOTOR, SURGICAL INSTRUMENT, AC-POWERED37 reports
- KINCISE 2000-00-001INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT33 reports
- KINCISE 200002102INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT14 reports
- KINCISE™ 1010-01-102MOTOR, SURGICAL INSTRUMENT, AC-POWERED10 reports
- KINCISE 200003002INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT7 reports
- KINCISE 200003001INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT5 reports
- KINCISE™ 1002-00-102MOTOR, SURGICAL INSTRUMENT, AC-POWERED4 reports
- KINCISE™ 1010-01-101MOTOR, SURGICAL INSTRUMENT, AC-POWERED4 reports
- KINCISE™ 1013-00-101MOTOR, SURGICAL INSTRUMENT, AC-POWERED2 reports
- KINCISE 2000-01-001BATTERY, REPLACEMENT, RECHARGEABLE2 reports
- KINCISE 200002002INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- KINCISE 200002301INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- KINCISE 200002003INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- KINCISE 200002012INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
Recent KINCISE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937311 ↗MalfunctionSep 18, 2026Material Fragmentation
It was reported that during an unspecified surgery, the KINCISE FEMORAL HEAD IMPACTOR device tip cracked and broke. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819119 ↗MalfunctionSep 17, 2026Material Fragmentation; Device-Device Incompatibility
It was reported that the KINCISE device snapped and no longer locked to hold broaches. It was not reported if the device was used in surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803543 ↗MalfunctionSep 17, 2026Component Missing; Detachment of Device or Device Component
It was reported that during in-house engineering evaluation, it was observed that the broach adapter device had missing components. It was noted by the reporter that during an unknown surgery the side button on the device came apart from the handle. It was not reported if there were any delays in the surgical procedure or if a spare device was available for use. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803281 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779197 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771706 ↗MalfunctionSep 4, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616290 ↗MalfunctionSep 4, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50615776 ↗MalfunctionSep 2, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573047 ↗MalfunctionSep 1, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542735 ↗MalfunctionAug 27, 2026Material Fragmentation
It was reported that during an unspecified surgical procedure, it was discovered that the emphasys str shell/liner impactor device was broken. It was not reported if there were any delays to the surgical procedure or if a spare device was available for use. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482488 ↗MalfunctionAug 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433672 ↗MalfunctionAug 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50430610 ↗MalfunctionAug 21, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379541 ↗MalfunctionAug 12, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221322 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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