Devices › Instrument, manual, surgical, general use
Device brand name · Instrument manual surgical general use
Surefire Scorpion Needle: medical device reports filed with FDA
290 reports name it, 2008–2026. Manufacturer given most often on reports: Arthrex. Product code MDM.
- 290
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 25
- reports, 12 months to August 2026
- 16 in the 12 months before
- 31.4%
- classified as malfunction
- 67% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
290 medical device reports received by FDA name the brand "Surefire Scorpion Needle" (instrument manual surgical general use); the manufacturer given most often on reports is Arthrex; received from April 2008 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
25 reports arrived in the 12 months to August 2026, up 56% from 16 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 injury (54.5%), malfunction (31.4%) and other (14.1%); across all instrument, manual, surgical, general use reports (product code MDM) death is recorded in 0.1% and malfunction in 67%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (63.4%), detachment of device component (17.6%) and device or device fragments location unknown (5.2%). The patient problems coded most often are device embedded in tissue or plaque, foreign body in patient and nonresorbable materials, unretrieved in body. 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 4,164 reports carrying product code MDM. 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 |
|---|---|---|---|
| Breakthe device broke | 184 | 63.4% | 54.8% |
| Detachment of device component | 51 | 17.6% | 7.6% |
| Device or device fragments location unknown | 15 | 5.2% | 1.6% |
| Device, or device fragments remain in patient | 13 | 4.5% | 1.5% |
| Difficult to removethe device was hard to remove | 13 | 4.5% | 4.3% |
| Entrapment of device | 12 | 4.1% | 2.3% |
| Tip breakage | 12 | 4.1% | 1.6% |
| Component missing | 11 | 3.8% | 1.4% |
| Material fragmentation | 8 | 2.8% | 1.9% |
| Detachment of device or device componentpart of the device came off | 6 | 2.1% | 3.1% |
| Replace | 6 | 2.1% | 3.3% |
| Component falling | 4 | 1.4% | 1.1% |
| Material twisted/bent | 3 | 1% | 1.6% |
| Positioning failure | 3 | 1% | 0.3% |
| Sticking | 3 | 1% | 0.9% |
| Bent | 2 | 0.7% | 0.6% |
| Component(s), broken | 2 | 0.7% | 1.1% |
| Device, removal of (non-implant) | 2 | 0.7% | 0.8% |
| Fracturea broken bone | 2 | 0.7% | 6.4% |
| Material separation | 2 | 0.7% | 1.1% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 99 | 34.1% |
| Foreign body in patientpart of a device left in the patient | 26 | 9% |
| Nonresorbable materials, unretrieved in body | 14 | 4.8% |
| Therapy/non-surgical treatment, additional | 5 | 1.7% |
| Surgery, prolonged | 4 | 1.4% |
| Foreign body, removal of | 3 | 1% |
| Tissue damage | 3 | 1% |
| Painpain, site not specified | 2 | 0.7% |
| Complaint, ill-defined | 1 | 0.3% |
| Discomfortdiscomfort | 1 | 0.3% |
| Osteopenia/ osteoporosis | 1 | 0.3% |
| Surgical procedure, additional | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Surefire Scorpion Needle | Product code MDM | All MAUDE reports |
|---|---|---|---|
| Reports | 290 | 4,164 | 26,136,888 |
| Share of that pool | — | 7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 54.5% | 30.9% | 36.2% |
| Classified as malfunction | 31.4% | 67% | 62.3% |
| Filed by the manufacturer | 93.4% | 91.6% | 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 MDM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Scorpion-Multifire Needle | 351 | 20 | 0% |
| Scorpion Needle, Knee | 281 | 74 | 0% |
| Multifire Scorpion Needle | 202 | 0 | 0% |
| Endopouch Retriever Spec Bag | 734 | 35 | 0% |
| R3 Straight Shell Impactor | 565 | 21 | 0% |
| Trauma Implant | 264 | 0 | 0.4% |
| Jagwire | 1,325 | 22 | 0.7% |
| Femoral Implant Impactor | 700 | 18 | 0% |
| Arthrex | 332 | 28 | 0% |
| Mi Z Handle Acet Reamer | 458 | 22 | 0% |
| Unkn Orthopaedic Reconstruction Dev | 239 | 17 | 0.4% |
| Knee Scorpion | 471 | 81 | 0% |
| 3612 Lite Glove | 163 | 0 | 0% |
| Journey Fem Impact Bumper Lt | 299 | 8 | 0% |
| Ref Ball Jnt Screwdriver Shaft | 187 | 15 | 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 Surefire Scorpion Needle reports
How many FDA reports name Surefire Scorpion Needle?
290 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 25 in the latest 12 months.
What kinds of events are reported?
injury (54.5%), malfunction (31.4%) and other (14.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (63.4%), detachment of device component (17.6%), device or device fragments location unknown (5.2%), device, or device fragments remain in patient (4.5%) and difficult to remove (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (93.4%) and voluntary reports (3.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Surefire Scorpion Needle 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.