Device brand name · Cerclage fixation
Sternal Zipfix With Needle Sterile: medical device reports filed with FDA
184 reports name it, 2012–2026. Manufacturer given most often on reports: Synthes. Product code JDQ.
- 184
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 12
- reports, 12 months to August 2026
- 22 in the 12 months before
- 67.9%
- classified as malfunction
- 49.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 184 reports that name the brand "Sternal Zipfix With Needle Sterile" (cerclage fixation), received between April 2012 and March 2026; the manufacturer given most often on reports is Synthes. Spellings of one product vary from report to report.
12 reports arrived in the 12 months to August 2026, down 45% from 22 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 (67.9%) and injury (32.1%); across all cerclage, fixation reports (product code JDQ) death is recorded in 1.1% and malfunction in 49.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are mechanical problem (19.6%), device operates differently than expected (18.5%) and break (17.9%). The patient problems coded most often are failure of implant, impaired healing and pain. 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 2,627 reports carrying product code JDQ. 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 |
|---|---|---|---|
| Mechanical problema mechanical problem | 36 | 19.6% | 11.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 34 | 18.5% | 12% |
| Breakthe device broke | 33 | 17.9% | 23.5% |
| Loose or intermittent connection | 8 | 4.3% | 1% |
| Failure to adhere or bond | 5 | 2.7% | 1.6% |
| Material separation | 5 | 2.7% | 0.7% |
| Device slipped | 3 | 1.6% | 4% |
| Insufficient device problem information | 3 | 1.6% | 5.7% |
| Component missing | 2 | 1.1% | 0.8% |
| Detachment of device component | 2 | 1.1% | 1% |
| Detachment of device or device componentpart of the device came off | 2 | 1.1% | 0.3% |
| Material protrusion/extrusion | 2 | 1.1% | 0.1% |
| Migration or expulsion of device | 2 | 1.1% | 1.1% |
| Device difficult to maintain | 1 | 0.5% | 0.2% |
| Difficult to advance | 1 | 0.5% | 0.4% |
| Difficult to insertthe device was hard to insert | 1 | 0.5% | 0.3% |
| Difficult to open or close | 1 | 0.5% | 0.3% |
| Fitting problem | 1 | 0.5% | 0% |
| Material disintegration | 1 | 0.5% | 0% |
| Nonstandard device | 1 | 0.5% | 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 |
|---|---|---|
| Failure of implant | 10 | 5.4% |
| Impaired healingslow healing | 8 | 4.3% |
| Painpain, site not specified | 7 | 3.8% |
| Hemorrhage/blood loss/bleeding | 5 | 2.7% |
| Chest painchest pain | 4 | 2.2% |
| Dyspneashortness of breath | 4 | 2.2% |
| No patient involvement | 4 | 2.2% |
| Reactiona reaction, type not specified | 4 | 2.2% |
| Wound dehiscencea wound reopened | 3 | 1.6% |
| Organ dehiscence | 1 | 0.5% |
| Tissue damage | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sternal Zipfix With Needle Sterile | Product code JDQ | All MAUDE reports |
|---|---|---|---|
| Reports | 184 | 2,627 | 26,136,888 |
| Share of that pool | — | 7% | 0% |
| Classified as death, per 1,000 reports | 0 | 11 | 9 |
| Classified as injury | 32.1% | 47.9% | 36.2% |
| Classified as malfunction | 67.9% | 49.5% | 62.3% |
| Filed by the manufacturer | 100% | 97.2% | 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 JDQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Application Instrument For Sternal Zipfix | 458 | 4 | 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 Sternal Zipfix With Needle Sterile reports
How many FDA reports name Sternal Zipfix With Needle Sterile?
184 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.
What kinds of events are reported?
malfunction (67.9%) and injury (32.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical problem (19.6%), device operates differently than expected (18.5%), break (17.9%), loose or intermittent connection (4.3%) and failure to adhere or bond (2.7%). 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 Sternal Zipfix With Needle Sterile 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.