Device manufacturer, as written on reports

Zimmer Surgical: medical device reports filed with FDA

16,551 reports name it as the manufacturer of the device involved, 2010–2026.

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.

16,551
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,668
reports, 12 months to August 2026: 1,969 in the 12 months before; 89.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

16,551 medical device reports received by FDA give Zimmer Surgical as the manufacturer of the device involved, 0.1% of the MAUDE database, from December 2010 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,668 reports arrived in the 12 months to August 2026, down 15% from 1,969 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 (89.2%), injury (10.6%) and death (0.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Zimmer Skin Graft Mesher	Expander, surgical, skin graft	3,361	285	0%
Zimmer Air Dermatome	Dermatome	2,503	372	0%
Handpiece Electric Dermatome	Dermatome	1,816	174	0%
Fan Spray Kit	Lavage, jet	847	173	0%
Hip Kit	Lavage, jet	648	135	0%
Dermatome AN Handpiece	Dermatome	443	117	0%
Air Dermatome Handpiece	Dermatome	407	0	0%
Z S G M Cutter 1 5 1 Ratio Caution Sharp	Expander, surgical, skin graft	341	17	0%
Electric Dermatome Handpiece	Dermatome	236	0	0%
Universal Oscillating Saw Attachment	Blade, saw, general & plastic surgery, surgical	229	0	0%
Universal Modular Electric/Battery Double	Motor, surgical instrument, ac-powered	221	0	0%
Z S G M Cutter 2 1 Ratio Caution Sharp	Expander, surgical, skin graft	219	6	0%
Dermatome Blades	Dermatome	168	5	0%
Air Dermatome Kit	Dermatome	87	0	0%
Disposable Mixing Bowl And Spatula	Mixer, cement, for clinical use	40	210	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
GFD	Dermatome	6,754	40.8%
FZW	Expander, surgical, skin graft	5,012	30.3%
FQH	Lavage, jet	1,932	11.7%
KCY	Tourniquet, pneumatic	716	4.3%
MOQ	Battery, replacement, rechargeable	541	3.3%
GFA	Blade, saw, general & plastic surgery, surgical	450	2.7%
HAB	Saw, powered, and accessories	367	2.2%
GEY	Motor, surgical instrument, ac-powered	244	1.5%
LOD	Bone cement	118	0.7%
JCX	Apparatus, suction, ward use, portable, ac-powered	68	0.4%

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

Death0.1%15

Injury10.6%1,758

Malfunction89.2%14,761

Other0.1%9

Not given0%8

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Zimmer Surgical reports

How many FDA device reports name Zimmer Surgical as manufacturer?

16,551 reports through August 2026, 1,668 of them in the latest 12 months.

Which of its brands appear most often?

Zimmer Skin Graft Mesher (3,361), Zimmer Air Dermatome (2,503), Handpiece Electric Dermatome (1,816), Fan Spray Kit (847) and Hip Kit (648).

Which device types does it report on?

dermatome (40.8%), expander, surgical, skin graft (30.3%), lavage, jet (11.7%) and tourniquet, pneumatic (4.3%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.