Reported Reactions

Devices › Prosthesis, hip, femoral component, cemented, metal

Device brand name · Prosthesis hip femoral component cemented metal

Accord Dual Ended Hex Driver: medical device reports filed with FDA

175 reports name it, 2018–2021. Manufacturer given most often on reports: Smith & Nephew. Product code JDG.

175
device reports naming the brand
0% of all MAUDE reports · about 21 a year
0
reports, 12 months to August 2026
0 in the 12 months before
92.6%
classified as malfunction
52.2% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

175 medical device reports received by FDA name the brand "Accord Dual Ended Hex Driver" (prosthesis hip femoral component cemented metal); the manufacturer given most often on reports is Smith & Nephew; received from May 2018 to November 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (92.6%) and injury (7.4%); across all prosthesis, hip, femoral component, cemented, metal reports (product code JDG) death is recorded in 0.2% and malfunction in 52.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material deformation (44.6%), break (21.7%) and naturally worn (11.4%). The patient problems coded most often are 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

059Sep 2021: 9Oct 2021: 0Nov 2021: 5Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 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

042832018: 820182019: 420192020: 8020202021: 832021

Event type and report source

Event type, as classified on the report

Death0%0
Injury7.4%13
Malfunction92.6%162
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%175
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 6,715 reports carrying product code JDG. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Material deformation7844.6%2.8%
Breakthe device broke3821.7%28.3%
Naturally worn2011.4%2.3%
Defective devicethe device was defective169.1%1.1%
Material separation63.4%0.3%
Crackthe device cracked52.9%3%
Connection problema connection problem42.3%1.5%
Degraded31.7%0.4%
Deformation due to compressive stress21.1%0.1%
Dull, blunt21.1%0.6%
Fracturea broken bone21.1%15.5%
Activation, positioning or separation problem10.6%0.1%
Device damaged prior to usethe device was damaged before use10.6%0.1%
Material integrity problema problem with the device material10.6%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)ReportsShare
No patient involvement2212.6%

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

In context

MeasureAccord Dual Ended Hex DriverProduct code JDGAll MAUDE reports
Reports1756,71526,136,888
Share of that pool—2.6%0%
Classified as death, per 1,000 reports029
Classified as injury7.4%47.3%36.2%
Classified as malfunction92.6%52.2%62.3%
Filed by the manufacturer100%97.9%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 JDG

BrandReportsLatest 12 monthsClassified as death
Femoral Implant Impactor700180%
R3 Offset Impactor418350%
Mi Z Handle Acet Reamer458220%
Rdce Frcps W/ Pts Brd41610%
T-Handle358170%
Reamer Handle165130%
Stem Impactor Rod20090%
Taper Sleeve Adapter 12/14 +21,02501.4%
Unknown Hip Implant1,11490.6%
Unkn TRIGEN INTERTAN Intertroch Antegr Nail16930%
Plus27600.4%
Unknown Stem1,857840.5%
Large Mod Head Adapt 12/14 +575021.7%
Unkn Orthopaedic Reconstruction Dev239170.4%
Unknown Depuy Xl Taper Sleeve Adaptor15300%

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 Accord Dual Ended Hex Driver reports

How many FDA reports name Accord Dual Ended Hex Driver?

175 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 (92.6%) and injury (7.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material deformation (44.6%), break (21.7%), naturally worn (11.4%), defective device (9.1%) and material separation (3.4%). 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 Accord Dual Ended Hex Driver 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.