Devices › Blade, saw, general & plastic surgery, surgical
Device brand name · Saw blades and accessories
Sagittal Blade: medical device reports filed with FDA
154 reports name it, 2008–2024. Manufacturer given most often on reports: Stryker Ireland. Product code GFA.
- 154
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 89.6%
- classified as malfunction
- 90.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 154 reports that name the brand "Sagittal Blade" (saw blades and accessories), received between May 2008 and July 2024; the manufacturer given most often on reports is Stryker Ireland. 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 (89.6%) and injury (10.4%); across all blade, saw, general & plastic surgery, surgical reports (product code GFA) death is recorded in 0% and malfunction in 90.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (58.4%), tear, rip or hole in device packaging (16.2%) and detachment of device component (7.1%). The patient problems coded most often are injury, device embedded in tissue or plaque and foreign body, removal of. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,883 reports carrying product code GFA. 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 | 90 | 58.4% | 30.4% |
| Tear, rip or hole in device packaging | 25 | 16.2% | 1.7% |
| Detachment of device component | 11 | 7.1% | 2.4% |
| Component falling | 10 | 6.5% | 1% |
| Difficult to open or remove packaging material | 10 | 6.5% | 0.3% |
| Device packaging compromised | 6 | 3.9% | 0.4% |
| Bent | 5 | 3.2% | 1.8% |
| Packaging problem | 4 | 2.6% | 0.7% |
| Component(s), broken | 3 | 1.9% | 0.3% |
| Device, removal of (non-implant) | 3 | 1.9% | 0.4% |
| Material fragmentation | 2 | 1.3% | 8.1% |
| Unsealed device packaging | 2 | 1.3% | 0.1% |
| Device contamination with chemical or other material | 1 | 0.6% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.6% | 6.2% |
| Device, or device fragments remain in patient | 1 | 0.6% | 0.1% |
| Insufficient device problem information | 1 | 0.6% | 0.2% |
| Metal shedding debris | 1 | 0.6% | 1.2% |
| Replace | 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 |
|---|---|---|
| Injurya physical injury | 5 | 3.2% |
| Device embedded in tissue or plaque | 4 | 2.6% |
| Foreign body, removal of | 4 | 2.6% |
| No patient involvement | 3 | 1.9% |
| Laceration(s) | 1 | 0.6% |
| Nonresorbable materials, unretrieved in body | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sagittal Blade | Product code GFA | All MAUDE reports |
|---|---|---|---|
| Reports | 154 | 5,883 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 10.4% | 8.5% | 36.2% |
| Classified as malfunction | 89.6% | 90.9% | 62.3% |
| Filed by the manufacturer | 100% | 94.8% | 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 GFA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown_InstrumentstIre_Product | 1,475 | 123 | 0% |
| Universal Oscillating Saw Attachment | 236 | 0 | 0% |
| Oscillating Saw Atch Large With Key | 157 | 12 | 0% |
| Universal Modular Electric/Battery Double | 238 | 0 | 0% |
| 2 5mm Drill Bit/Qc/Gold/110mm | 320 | 14 | 0% |
| Conmed | 900 | 89 | 0.2% |
| 4 0mm Aggressive Plus Cutter Formula 5bx | 150 | 0 | 0% |
| Micro Sagittal Saw | 1,395 | 0 | 0% |
| Unknown Instruments Product | 400 | 23 | 0.8% |
| Micro Oscillating Saw | 346 | 0 | 0% |
| Unknown_Endoscopy_Product | 241 | 22 | 0.4% |
| Stryker | 559 | 5 | 1.3% |
| Sagittal Saw Attachment | 1,505 | 64 | 0% |
| Air Dermatome Handpiece | 511 | 0 | 0% |
| Oscill-Saw-Attachm F/532 001 532 010 532 | 327 | 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 Sagittal Blade reports
How many FDA reports name Sagittal Blade?
154 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 (89.6%) and injury (10.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (58.4%), tear, rip or hole in device packaging (16.2%), detachment of device component (7.1%), component falling (6.5%) and difficult to open or remove packaging material (6.5%). 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 Sagittal Blade 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.