Reported Reactions

Devices › Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment

Device brand name · Arthroscopy shaver handpiece

Advantage Turbo Shaver 2 Button Basic: medical device reports filed with FDA

228 reports name it, 2006–2007. Manufacturer given most often on reports: Conmed Linvatec. Product code HWE.

228
device reports naming the brand
0% of all MAUDE reports · about 11 a year
0
reports, 12 months to August 2026
0 in the 12 months before
99.6%
classified as malfunction
97.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

228 medical device reports received by FDA name the brand "Advantage Turbo Shaver 2 Button Basic" (arthroscopy shaver handpiece); the manufacturer given most often on reports is Conmed Linvatec; received from January 2006 to December 2007. 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 (99.6%) and other (0.4%); across all instrument, surgical, orthopedic, ac-powered motor and accessory/attachment reports (product code HWE) death is recorded in 0% and malfunction in 97.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device issue (21.5%), self-activation or keying (19.7%) and failure, intermittent (8.3%). The patient problems coded most often are no patient involvement, surgical procedure aborted/stopped and blister(s). 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

No report naming Advantage Turbo Shaver 2 Button Basic was received in the five years to August 2026; the latest was received in December 2007.

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction99.6%227
Other0.4%1
Not given0%0

Who filed the report

Manufacturer report100%228
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 50,440 reports carrying product code HWE. 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 issuea problem with the device4921.5%0.1%
Self-activation or keying4519.7%0.7%
Failure, intermittent198.3%0%
Replace187.9%0.1%
Device inoperablethe device could not be used167%6.8%
Device remains activated156.6%1.2%
Device displays incorrect message135.7%0.1%
Failure to power up135.7%0.6%
Malfunction135.7%0%
Noise73.1%0%
Loss of powerthe device lost power62.6%0.7%
Repair62.6%0%
Device stops intermittentlythe device stopped now and then52.2%0.8%
Other (for use when an appropriate device code cannot be identified)41.8%0%
System fails to activate41.8%0%
Defective component31.3%0.8%
Defective devicethe device was defective20.9%1%
Failure to reset10.4%0%
Leak/splashthe device leaked10.4%1.2%

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 involvement93.9%
Surgical procedure aborted/stopped41.8%
Blister(s)10.4%
Burn, thermal10.4%
Hospitalization required10.4%
Osteointegration, inadequate10.4%
Surgery, prolonged10.4%
Surgical procedure10.4%
Surgical procedure, delayed10.4%
Therapy/non-surgical treatment, additional10.4%
Treatment with medication(s)10.4%

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

In context

MeasureAdvantage Turbo Shaver 2 Button BasicProduct code HWEAll MAUDE reports
Reports22850,44026,136,888
Share of that pool—0.5%0%
Classified as death, per 1,000 reports009
Classified as injury0%2.3%36.2%
Classified as malfunction99.6%97.5%62.3%
Filed by the manufacturer100%99.3%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 HWE

BrandReportsLatest 12 monthsClassified as death
Small Battery Drive2,43900%
Colibri1,47200%
Electric Pen Drive 60 000 Rpm1,486940%
Sagittal Saw Attachment1,505640%
Smartlife Large Aspetic Housing1,13220%
Sagittal Saw Attachment Long For Trs1,039900%
Quick Coupling For K-Wires744280%
Epd 60000 Rpm73700%
Air Oscillator65700%
Chuck With Key/Drill Speed For Trs655940%
Small Battery Drive Colibri63300%
Modular Calcar Planer Sml515300%
Sagittal Saw Attachment For Trs428770%
System 6 Sagittal Saw69800%
Unium Modular Handpiece4031370%

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 Advantage Turbo Shaver 2 Button Basic reports

How many FDA reports name Advantage Turbo Shaver 2 Button Basic?

228 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 (99.6%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device issue (21.5%), self-activation or keying (19.7%), failure, intermittent (8.3%), replace (7.9%) and device inoperable (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 Advantage Turbo Shaver 2 Button Basic 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.