Device brand name · Impactor
Impactor F/Pfna Blade: medical device reports filed with FDA
284 reports name it, 2013–2024. Manufacturer given most often on reports: Synthes Bettlach. Product code HWA.
- 284
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 0
- reports, 12 months to August 2026
- 2 in the 12 months before
- 87.3%
- classified as malfunction
- 98% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
284 medical device reports received by FDA name the brand "Impactor F/Pfna Blade" (impactor); the manufacturer given most often on reports is Synthes Bettlach; received from January 2013 to December 2024. 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, against 2 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 (87.3%) and injury (12.7%); across all impactor reports (product code HWA) death is recorded in 0% and malfunction in 98%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (42.6%), device-device incompatibility (13%) and mechanical jam (9.2%). The patient problems coded most often are no patient involvement, sedation and foreign body in patient. 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 19,425 reports carrying product code HWA. 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 | 121 | 42.6% | 69.8% |
| Device-device incompatibility | 37 | 13% | 6% |
| Mechanical jam | 26 | 9.2% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 21 | 7.4% | 0.1% |
| Detachment of device or device componentpart of the device came off | 12 | 4.2% | 0.6% |
| Loose or intermittent connection | 12 | 4.2% | 0.3% |
| Detachment of device component | 11 | 3.9% | 0.5% |
| Sticking | 11 | 3.9% | 0.2% |
| Material fragmentation | 7 | 2.5% | 0.3% |
| Fitting problem | 4 | 1.4% | 0.1% |
| Unintended movement | 4 | 1.4% | 0.5% |
| Crackthe device cracked | 3 | 1.1% | 8% |
| Device slipped | 3 | 1.1% | 0.1% |
| Separation failure | 3 | 1.1% | 0% |
| Component falling | 2 | 0.7% | 0.1% |
| Difficult to insertthe device was hard to insert | 2 | 0.7% | 0.1% |
| Improper or incorrect procedure or method | 2 | 0.7% | 0% |
| Material separation | 2 | 0.7% | 0.1% |
| Migration or expulsion of device | 2 | 0.7% | 0% |
| Compatibility problem | 1 | 0.4% | 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 |
|---|---|---|
| No patient involvement | 27 | 9.5% |
| Sedationdrowsiness from a medicine | 9 | 3.2% |
| Foreign body in patientpart of a device left in the patient | 5 | 1.8% |
| Device embedded in tissue or plaque | 4 | 1.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.4% |
| Bone fracture(s) | 1 | 0.4% |
| Eye injury | 1 | 0.4% |
| Injurya physical injury | 1 | 0.4% |
| Not applicable | 1 | 0.4% |
| Oversedation | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Impactor F/Pfna Blade | Product code HWA | All MAUDE reports |
|---|---|---|---|
| Reports | 284 | 19,425 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 12.7% | 1.8% | 36.2% |
| Classified as malfunction | 87.3% | 98% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 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 HWA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pinn Straight Cup Impactor | 4,807 | 315 | 0% |
| Attune Femoral Impactor | 3,328 | 121 | 0% |
| Attune Fb Tibial Impactor | 1,954 | 114 | 0% |
| Attune Impaction Handle | 1,975 | 64 | 0% |
| Attune Rp Tibial Impactor | 1,025 | 32 | 0% |
| Sp2 Tibial Radel Impactor | 1,039 | 2 | 0% |
| Duraloc Str Cup Impactor | 909 | 57 | 0% |
| Concave Impactor Tip | 342 | 18 | 0% |
| S/C Trial Handle Angled | 330 | 32 | 0% |
| Duraloc Curved Cup Impactor | 310 | 19 | 0% |
| Attune | 1,958 | 1,944 | 0% |
| Pinnacle | 689 | 499 | 0.1% |
| Sigma Hp Fbt Keel Punch Impact | 219 | 0 | 0% |
| Sigma Hp Fem Notch Impactor | 262 | 8 | 0% |
| Sp 2 Femoral Impactor | 246 | 2 | 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 Impactor F/Pfna Blade reports
How many FDA reports name Impactor F/Pfna Blade?
284 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 (87.3%) and injury (12.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (42.6%), device-device incompatibility (13%), mechanical jam (9.2%), device operates differently than expected (7.4%) and detachment of device or device component (4.2%). 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 Impactor F/Pfna Blade 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.