Devices › Bur, surgical, general & plastic surgery
Device brand name · Bur surgical general & plastic surgery - craniotome
Standard Craniotome Black Max: medical device reports filed with FDA
158 reports name it, 2013–2019. Manufacturer given most often on reports: Depuy Synthes Power Tools. Product code GFF.
- 158
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.7%
- classified as malfunction
- 90.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 158 reports that name the brand "Standard Craniotome Black Max" (bur surgical general & plastic surgery - craniotome), received between March 2013 and June 2019; the manufacturer given most often on reports is Depuy Synthes Power Tools. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.7%) and injury (1.3%); across all bur, surgical, general & plastic surgery reports (product code GFF) death is recorded in 0% and malfunction in 90.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (31.6%), bent (25.3%) and overheating of device (5.1%). The patient problems coded most often are no patient involvement, foreign body in patient and injury. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Standard Craniotome Black Max was received in the five years to August 2026; the latest was received in June 2019.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,113 reports carrying product code GFF. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 50 | 31.6% | 32.8% |
| Bent | 40 | 25.3% | 3.7% |
| Overheating of device | 8 | 5.1% | 5.9% |
| Device inoperablethe device could not be used | 5 | 3.2% | 1.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 3.2% | 7.5% |
| Difficult to insertthe device was hard to insert | 5 | 3.2% | 1.4% |
| Entrapment of device | 3 | 1.9% | 0.6% |
| Sticking | 3 | 1.9% | 1% |
| Component missing | 2 | 1.3% | 0.5% |
| Device slipped | 2 | 1.3% | 0.8% |
| Loose or intermittent connection | 2 | 1.3% | 0.4% |
| Naturally worn | 2 | 1.3% | 0.3% |
| Burst container or vessel | 1 | 0.6% | 0% |
| Corrodedthe device corroded | 1 | 0.6% | 0.4% |
| Defective devicethe device was defective | 1 | 0.6% | 0.9% |
| Detachment of device component | 1 | 0.6% | 3.4% |
| Device contamination with chemical or other material | 1 | 0.6% | 9.7% |
| Device difficult to setup or prepare | 1 | 0.6% | 0.1% |
| Difficult to removethe device was hard to remove | 1 | 0.6% | 0.7% |
| Failure to power up | 1 | 0.6% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 34 | 21.5% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.6% |
| Injurya physical injury | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Standard Craniotome Black Max | Product code GFF | All MAUDE reports |
|---|---|---|---|
| Reports | 158 | 2,113 | 26,136,888 |
| Share of that pool | — | 7.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 1.3% | 8.2% | 36.2% |
| Classified as malfunction | 98.7% | 90.6% | 62.3% |
| Filed by the manufacturer | 100% | 96.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code GFF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| 1 85mm X 16mm Fluted Router | 211 | 0 | 0% |
| 4 0mm Aggressive Plus Cutter Formula 5bx | 150 | 0 | 0% |
| Unknown_InstrumentstIre_Product | 1,475 | 123 | 0% |
| 2 15mm X 22mm Spiral Router | 181 | 0 | 0% |
| 2 5mm Drill Bit/Qc/Gold/110mm | 320 | 14 | 0% |
| Cable Tensioner | 278 | 0 | 0% |
| Sterling | 4,963 | 300 | 0.1% |
| 8cm Angle Attachment | 1,476 | 6 | 0% |
| Conmed | 900 | 89 | 0.2% |
| 2 0mm Cannulated Drill Bit/Qc 150mm | 183 | 3 | 0% |
| Microaire | 176 | 0 | 0.6% |
| Stryker | 559 | 5 | 1.3% |
| Synthes | 470 | 0 | 0.6% |
| Twist Drill | 160 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Standard Craniotome Black Max reports
How many FDA reports name Standard Craniotome Black Max?
158 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (98.7%) and injury (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (31.6%), bent (25.3%), overheating of device (5.1%), device inoperable (3.2%) and device operates differently than expected (3.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Standard Craniotome Black Max was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.