Reported Reactions

Devices › Rod, fixation, intramedullary and accessories

Device brand name · Rod fixation intramedullary and accessories

Cannulated Connecting Screw: medical device reports filed with FDA

206 reports name it, 2015–2026. Manufacturer given most often on reports: Synthes. Product code HSB.

206
device reports naming the brand
0% of all MAUDE reports · about 19 a year
27
reports, 12 months to August 2026
26 in the 12 months before
90.8%
classified as malfunction
33% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

206 medical device reports received by FDA name the brand "Cannulated Connecting Screw" (rod fixation intramedullary and accessories); the manufacturer given most often on reports is Synthes; received from June 2015 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

27 reports arrived in the 12 months to August 2026, close to the 26 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 (90.8%) and injury (9.2%); across all rod, fixation, intramedullary and accessories reports (product code HSB) death is recorded in 0.3% and malfunction in 33%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device-device incompatibility (65%), material twisted/bent (11.2%) and break (10.7%). The patient problems coded most often are limb fracture, sedation and no patient involvement. 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

0612Sep 2021: 2Oct 2021: 2Nov 2021: 1Dec 2021: 22022Jan 2022: 1Feb 2022: 2Mar 2022: 8Apr 2022: 1May 2022: 2Jun 2022: 0Jul 2022: 0Aug 2022: 2Sep 2022: 0Oct 2022: 1Nov 2022: 0Dec 2022: 12023Jan 2023: 0Feb 2023: 0Mar 2023: 8Apr 2023: 2May 2023: 0Jun 2023: 0Jul 2023: 2Aug 2023: 0Sep 2023: 0Oct 2023: 1Nov 2023: 0Dec 2023: 02024Jan 2024: 2Feb 2024: 0Mar 2024: 5Apr 2024: 0May 2024: 12Jun 2024: 3Jul 2024: 3Aug 2024: 0Sep 2024: 2Oct 2024: 12Nov 2024: 0Dec 2024: 12025Jan 2025: 2Feb 2025: 2Mar 2025: 0Apr 2025: 6May 2025: 0Jun 2025: 1Jul 2025: 0Aug 2025: 0Sep 2025: 3Oct 2025: 3Nov 2025: 2Dec 2025: 32026Jan 2026: 1Feb 2026: 0Mar 2026: 0Apr 2026: 5May 2026: 0Jun 2026: 6Jul 2026: 4Aug 2026: 0

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

020402015: 1020152016: 192017: 920172018: 142019: 1820192020: 72021: 2020212022: 182023: 1320232024: 402025: 2220252026: 16

Event type and report source

Event type, as classified on the report

Death0%0
Injury9.2%19
Malfunction90.8%187
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%206
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 37,835 reports carrying product code HSB. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Device-device incompatibility13465%7.8%
Material twisted/bent2311.2%1.3%
Breakthe device broke2210.7%21.8%
Noise, audible115.3%0.1%
Material deformation94.4%1.1%
Mechanical jam94.4%1.1%
Failure to align62.9%1.9%
Fitting problem62.9%0.8%
Device operates differently than expectedthe device behaved unexpectedly41.9%2.7%
Sticking31.5%0.5%
Disassembly21%0.1%
Unintended movement21%0.7%
Detachment of device or device componentpart of the device came off10.5%0.5%
Device disinfection or sterilization issue10.5%0%
Difficult to removethe device was hard to remove10.5%0.8%
Dull, blunt10.5%0%
Entrapment of device10.5%0.2%
Failure to adhere or bond10.5%0.4%
Material integrity problema problem with the device material10.5%0.3%
Physical resistance/sticking10.5%0.3%

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)ReportsShare
Limb fracture62.9%
Sedationdrowsiness from a medicine62.9%
No patient involvement52.4%
Not applicable10.5%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureCannulated Connecting ScrewProduct code HSBAll MAUDE reports
Reports20637,83526,136,888
Share of that pool—0.5%0%
Classified as death, per 1,000 reports039
Classified as injury9.2%66.3%36.2%
Classified as malfunction90.8%33%62.3%
Filed by the manufacturer100%98.9%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 HSB

BrandReportsLatest 12 monthsClassified as death
Sign Im Nail2,3012260%
UNK - Nails: TFNA412240%
Trochanteric Nail Kit Ti Gamma3 11x180mm X 12536600.3%
Unknown T2 Scn35500%
SIGN Fin NAIL335500%
UNK - Nail Head Elements: TFNA Helical Blade270130%
Unk - Nail Head Elements Pfna Blade26010%
Radiolucent Insertion Handle Frn256140%
Helical Blade/Screw Coupling Screw226410%
Precice Stryde System22600%
Lag Screw Driver223140%
Unknown T2 Tibia Nail22300%
Target Device Gamma3 300x160mm23910%
Unknown T2 Alpha Tibia Nail1991750%
Unknown Kie Product219210.5%

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 Cannulated Connecting Screw reports

How many FDA reports name Cannulated Connecting Screw?

206 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 27 in the latest 12 months.

What kinds of events are reported?

malfunction (90.8%) and injury (9.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device-device incompatibility (65%), material twisted/bent (11.2%), break (10.7%), noise, audible (5.3%) and material deformation (4.4%). 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 Cannulated Connecting Screw 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.