Extractor: medical device reports filed with FDA

3,519 reports carry this product code, 1993–2026; 11 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,519
reports with this product code: 0% of all MAUDE reports; 311
reports, 12 months to August 2026: 265 in the 12 months before; 93%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code HWB is FDA's classification for "Extractor" (orthopedic panel), a class 1 device. 3,519 medical device reports carry this product code, 0% of the MAUDE database, from January 1993 to August 2026.

311 reports arrived in the 12 months to August 2026, up 17% from 265 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 (93%), injury (6.9%) and other (0.1%). 11 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Attune Tibial Trial Extractor	419	22	0%	100%
Pinn Poly Extractor	270	23	0%	99.7%
Reclaim Assem Upper Pull Rod	170	13	0%	97.5%
Attune Pin Puller	168	17	0%	100%
Dhs/Dcs Coupling Screw	168	12	0%	88.4%
Pinn Esc Liner Extractor Tip	148	19	0%	100%
Impactor F/Pfna Blade	12	0	0%	87.3%
ELEVATE Spinal System	2	46	0%	88.9%
Attune	1	1,944	0%	56.5%
Attune Rp Ps Artic Surf Sz7	1	22	0%	99.6%
Discovery Elbow	1	0	0%	1.1%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Depuy Ireland - 9616671	286	8.1%
Synthes Bettlach	53	1.5%
Depuy Ireland 9616671	48	1.4%
Synthes Hagendorf	47	1.3%
Stryker Spine Bordeaux	28	0.8%
Tornier S	12	0.3%
Stryker Osteosynthesis Kiel	5	0.1%
Depuy Ireland	4	0.1%
Depuy Orthopaedics	4	0.1%
Biomet Orthopedics	2	0.1%
Synthes USA	2	0.1%
Biomet France R L	1	0%
Depuy Orthopaedics US 1818910	1	0%
Limacorporate	1	0%
Smith & Nephew	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%0

Injury6.9%243

Malfunction93%3,272

Other0.1%3

Not given0%1

Who filed

Manufacturer report98.5%3,466

Voluntary report0.7%26

User facility report0%0

Distributor report0.1%3

Not given0.7%24

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,776	50.5%
Device-device incompatibility	511	14.5%
Material deformation	282	8%
Material twisted/bent	261	7.4%
Fracturea broken bone	192	5.5%
Naturally worn	164	4.7%
Mechanical jam	93	2.6%
Crackthe device cracked	76	2.2%
Difficult to removethe device was hard to remove	58	1.6%
Bent	49	1.4%
Material fragmentation	40	1.1%
Material integrity problema problem with the device material	40	1.1%
Detachment of device component	27	0.8%
Device operates differently than expectedthe device behaved unexpectedly	27	0.8%
Entrapment of device	23	0.7%
Corrodedthe device corroded	21	0.6%
Scratched material	19	0.5%
Dull, blunt	16	0.5%
Component missing	15	0.4%
Detachment of device or device componentpart of the device came off	15	0.4%

Questions about extractor reports

What is product code HWB?

FDA's classification code for "Extractor", class 1, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,519 reports through August 2026, 311 of them in the latest 12 months.

Which brands appear most often?

Attune Tibial Trial Extractor (419), Pinn Poly Extractor (270), Reclaim Assem Upper Pull Rod (170), Attune Pin Puller (168) and Dhs/Dcs Coupling Screw (168). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.