Reported Reactions

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

Device brand name · Instrument surgical orthopedic dc-powered motor

Adj Pin Collet 2 0-3 2mm: medical device reports filed with FDA

195 reports name it, 2009–2014. Manufacturer given most often on reports: Stryker Instruments Kalamazoo. Product code KIJ.

195
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
99.5%
classified as malfunction
97.2% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 195 reports that name the brand "Adj Pin Collet 2 0-3 2mm" (instrument surgical orthopedic dc-powered motor), received between June 2009 and June 2014; the manufacturer given most often on reports is Stryker Instruments Kalamazoo. Spellings of one product vary from report to report.

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 (99.5%) and injury (0.5%); across all instrument, surgical, orthopedic, dc-powered motor and accessory/attachment reports (product code KIJ) death is recorded in 0.1% and malfunction in 97.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are sticking (33.8%), device slipped (25.1%) and mechanical jam (13.3%). The patient problems coded most often are no patient involvement. 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 Adj Pin Collet 2 0-3 2mm was received in the five years to August 2026; the latest was received in June 2014.

By year received

0661322009: 1020092010: 4020102011: 13220112012: 420122013: 420132014: 52014

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.5%1
Malfunction99.5%194
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%195
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 2,860 reports carrying product code KIJ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Sticking6633.8%7.3%
Device slipped4925.1%7.1%
Mechanical jam2613.3%3.1%
Device operates differently than expectedthe device behaved unexpectedly73.6%4.8%
Fitting problem63.1%0.3%
Metal shedding debris63.1%3%
Naturally worn63.1%0.8%
Component falling52.6%2.7%
Detachment of device component52.6%3.2%
Device inoperablethe device could not be used31.5%0.9%
Breakthe device broke21%7%
Device contamination with chemical or other material21%2.1%
Difficult to removethe device was hard to remove21%0%
Fluid/blood leak21%12.6%
Mechanical problema mechanical problem21%0.5%
Application interface becomes non-functional or program exits abnormally10.5%0%
Device contaminated during manufacture or shipping10.5%0%
Device contamination with body fluid10.5%1.2%
Device or device fragments location unknown10.5%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)ReportsShare
No patient involvement9850.3%

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

In context

MeasureAdj Pin Collet 2 0-3 2mmProduct code KIJAll MAUDE reports
Reports1952,86026,136,888
Share of that pool—6.8%0%
Classified as death, per 1,000 reports019
Classified as injury0.5%2.7%36.2%
Classified as malfunction99.5%97.2%62.3%
Filed by the manufacturer100%99.2%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 KIJ

BrandReportsLatest 12 monthsClassified as death
System 6 Sagittal Saw69800%
Dual Trigger Rotary36200%
System 6 Aseptic Housing Assy46100%
System 5 Sagittal Saw21100%
System 5 Dual Trigger Rotary Handpiece15200%
Single Trigger Rotary25200%
Pin Collet40800%
Sys 6 Recip18600%
Cordless Driver 347600%
Wire Collet32830%
Sagittal Saw Attachment1,505640%
System 7 Sag Saw17000%
Driver214270%
Neptune Rover With Smoke Evac And Power Pole26600.4%
System 7 Dual Trigger Rotary23400%

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 Adj Pin Collet 2 0-3 2mm reports

How many FDA reports name Adj Pin Collet 2 0-3 2mm?

195 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 (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

sticking (33.8%), device slipped (25.1%), mechanical jam (13.3%), device operates differently than expected (3.6%) and fitting problem (3.1%). 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 Adj Pin Collet 2 0-3 2mm 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.