Devices › Guide, surgical, instrument
Device brand name · Guide surgical instrument
Blade/Screw Guide Sleeve: medical device reports filed with FDA
373 reports name it, 2015–2026. Manufacturer given most often on reports: Synthes. Product code FZX.
- 373
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 40
- reports, 12 months to August 2026
- 39 in the 12 months before
- 96%
- classified as malfunction
- 82.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
373 medical device reports received by FDA name the brand "Blade/Screw Guide Sleeve" (guide surgical instrument); the manufacturer given most often on reports is Synthes; received from January 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
40 reports arrived in the 12 months to August 2026, close to the 39 of 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 (96%) and injury (4%); across all guide, surgical, instrument reports (product code FZX) death is recorded in 0% and malfunction in 82.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device-device incompatibility (59.2%), material deformation (11.3%) and material twisted/bent (10.7%). The patient problems coded most often are no patient involvement, sedation and death. 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 8,517 reports carrying product code FZX. 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 |
|---|---|---|---|
| Device-device incompatibility | 221 | 59.2% | 26.7% |
| Material deformation | 42 | 11.3% | 6.8% |
| Material twisted/bent | 40 | 10.7% | 4.2% |
| Breakthe device broke | 32 | 8.6% | 24% |
| Mechanical jam | 32 | 8.6% | 3.6% |
| Fitting problem | 19 | 5.1% | 2.7% |
| Failure to align | 15 | 4% | 5.4% |
| Material integrity problema problem with the device material | 13 | 3.5% | 1.1% |
| Bent | 7 | 1.9% | 1.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 1.9% | 4.3% |
| Sticking | 5 | 1.3% | 0.9% |
| Contamination /decontamination problem | 2 | 0.5% | 0.4% |
| Device difficult to maintain | 2 | 0.5% | 0.2% |
| Component incompatible | 1 | 0.3% | 0% |
| Component missing | 1 | 0.3% | 0.8% |
| Crackthe device cracked | 1 | 0.3% | 0.5% |
| Defective devicethe device was defective | 1 | 0.3% | 0.2% |
| Degraded | 1 | 0.3% | 0.3% |
| Device damaged by another device | 1 | 0.3% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.3% | 0% |
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 | 35 | 9.4% |
| Sedationdrowsiness from a medicine | 3 | 0.8% |
| Deaththe patient died; cause not stated by this term | 1 | 0.3% |
| Device embedded in tissue or plaque | 1 | 0.3% |
| Injurya physical injury | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Blade/Screw Guide Sleeve | Product code FZX | All MAUDE reports |
|---|---|---|---|
| Reports | 373 | 8,517 | 26,136,888 |
| Share of that pool | — | 4.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 4% | 17.3% | 36.2% |
| Classified as malfunction | 96% | 82.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.4% | 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 FZX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| 130 Deg Aiming Arm F/Trochanteric Fixation Nails | 215 | 0 | 0% |
| Disposable Mixing Bowl And Spatula | 577 | 210 | 0% |
| UNK - Guide/Compression/K-Wires | 213 | 14 | 0% |
| Eea | 4,922 | 542 | 0.8% |
| G7 Positioning Guide Rod | 216 | 32 | 0% |
| Rsp | 1,369 | 0 | 0% |
| Flexible Silicone Drill Driver | 206 | 26 | 0% |
| Empowr 3d Knee | 607 | 0 | 0% |
| Quantum | 183 | 35 | 0.5% |
| Aiming Arm/ Radiolucent | 465 | 82 | 0% |
| Anatomage Guide | 243 | 0 | 0% |
| Biomet | 337 | 0 | 0.3% |
| Driving Cap | 497 | 65 | 0% |
| Empowr Hip | 150 | 0 | 0% |
| Helical Blade Coupling Screw | 305 | 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 Blade/Screw Guide Sleeve reports
How many FDA reports name Blade/Screw Guide Sleeve?
373 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 40 in the latest 12 months.
What kinds of events are reported?
malfunction (96%) and injury (4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device-device incompatibility (59.2%), material deformation (11.3%), material twisted/bent (10.7%), break (8.6%) and mechanical jam (8.6%). 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 Blade/Screw Guide Sleeve 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.