SpeedRecalls & reported problems across all models
Biomedical Enterprises, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 9 models of Speed by Biomedical Enterprises, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2016 and May 21, 2021 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Break” (13 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Speed problems
Device problems
- Break13
- Detachment of Device or Device Component9
- Appropriate Device Problem Term/Code Not Available2
- Crack1
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient9
- No Clinical Signs, Symptoms or Conditions3
- Pain2
- No Code Available1
- No Patient Involvement1
- Not Applicable1
Speed models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Speed SE-1818Staple, Fixation, Bone8 reports
- Speed SE-2020Staple, Fixation, Bone5 reports
- Speed SE-2520Staple, Fixation, Bone5 reports
- Speed SE-1515Staple, Fixation, Bone2 reports
- Speed DK-265Kit, Surgical Instrument, Disposable2 reports
- Speed SE-1815Staple, Fixation, Bone1 report
- Speed SE-2015Staple, Fixation, Bone1 report
- Speed DK-265-SKit, Surgical Instrument, Disposable1 report
- Speed SG-3Staple, Fixation, Bone1 report
Recent Speed adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE OF THE SPEED COMPRESSION IMPLANT KIT FELL OFF OF THE INSERTER WHILE STILL IN THE PACKAGING. THE ISSUE HAPPENED DURING SHIPPING WHILE AT THE OFFICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 15X15X15MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11866548 ↗MalfunctionJan 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE STOCK CHECK, IT WAS DISCOVERED THAT THE SPEED CCI PACKET¿S CCI IMPLANT HAD FALLEN OUT OF THE APPLICATOR. THE SPEED CCI PACKET CANNOT BE USED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SPEED 15X15X15MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11250536 ↗MalfunctionDec 29, 2020Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE DRILL BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW ITEM. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) SPEED DRILL KIT WITH 2.65MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11091010 ↗MalfunctionJul 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE STAPLE HAS COME OFF THE INSERTER TOOL AND RENDERING IT USELESS. IT WAS UNKNOWN HOW IT HAPPENED AND WHEN IT WAS DISCOVERED. THERE WAS NO SURGERY AND PATIENT INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SPEED COMPRESSION IMPLANT KIT 18X18X18MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10221135 ↗MalfunctionApr 21, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, A SPEEDARC IMPLANT SIZING GUIDE WAS DAMAGED AND BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEEDARC IMPLANT SIZING GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9982630 ↗MalfunctionMar 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE RESTOCKING THE STERILE IMPLANT TOTE, IT WAS NOTICED THAT THE STAPLE WAS DEPLOYED FROM THE HANDLE IN THE PACKAGE. THIS RENDERS THE DEVICE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SPEED COMPRESSION IMPLANT KIT 20X15X15MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9904336 ↗MalfunctionMar 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A LEFT MIDFOOT FUSION WITH A REPAIR OF PERONEAL TENDON WITH BONE GRAFT, THE COMPRESSION IMPLANT HAD LOOSENED FROM INSERTION HANDLE DURING TRANSPORT AND FULLY DETACHED WHILE THE BOX WAS BEING OPENED. THE IMPLANT WAS UNABLE TO BE INSERTED AS COMPRESSION HAD ALREADY INITIATED UPON RELEASE FROM HANDLE, MEANING IT WOULD NO LONGER MATCH UP TO THE PRE-DRILLED HOLES. PATIENT STATUS AND SURGICAL DELAY WAS UNKNOWN. THIS IS REPORT 1 OF 1 (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9884436 ↗MalfunctionJan 30, 2020Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS IMPLANT FRACTURES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9648994 ↗MalfunctionDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE ITEM WAS OPENED WITHIN THEATRE BUT THE STAPLE WAS DISLODGED FROM THE HANDLE. THE ITEM WAS DISPOSED OF AS PER HOSPITAL POLICY. NO TIME ADDED TO THE PROCEDURE. PATIENT DETAILS UNAVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9452632 ↗MalfunctionOct 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN CHECKING THE ORTHOKIT CCI BMW-SPEED SE-2520, A PACKAGED AND STILL UNOPENED CCI IMPLANT WAS DAMAGED. IT WAS THEN REMOVED FROM THE ORTHOKIT. THE CCI IMPLANT WAS NO LONGER PLACED ON THE INSERTION INSTRUMENT IN ITS UNOPENED PACKAGING AND WAS TRIGGERED AND NO LONGER READY FOR USE. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 25 X 20 X 20 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9141279 ↗MalfunctionApr 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE CLAMP OF THE SPEED COMPRESSION IMPLANT KIT HAS RELEASED FROM THE INSTRUMENT INSIDE OF THE STERILE PACKAGING. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8542020 ↗MalfunctionFeb 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, WHILE THE SCRUB STAFF WAS PREPARING FOR AN UNKNOWN PROCEDURE, THE STAFF NOTICED THE SPEED COMPRESSION IMPLANT KIT WAS NOT FULLY CONSTRAINED. IT WAS IN AN OPEN POSITION AND PACKAGING WAS VISIBLY INCORRECT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEED 20 X 20 X 20MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8343708 ↗InjurySep 28, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A FOOT SURGERY ON (B)(6) 2018 WHEREIN THE SURGEON IMPLANTED TWO (2) SPEED COMPRESSION IMPLANT KIT. THE PATIENT WAS SEEN POST OPERATIVELY ON (B)(6) 2018 AND HAD AN X-RAY WHICH REVEALED ONE(1) STAPLE HAD A BROKEN LEG. NO ACTION TO BE TAKEN AS PER SURGEON'S ADVISED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS GOOD. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: No Code Available; Not Applicable
MAUDE report 7920855 ↗MalfunctionJun 27, 2018Break; Break
IT WAS REPORTED THAT DURING A PODIATRY PROCEDURE ON (B)(6) 2018, THE DRILL BIT FROM THE 2.65MM DRILL KIT (DK) BROKE. WHILE USING THE STERILE DRILL KIT TO IMPLANT BME SPEED TITAN STAPLES, THE DRILL BIT IN THE KIT BROKE INTO TWO PIECES WHILE THE DOCTOR WAS DRILLING. BOTH FRAGMENTS WERE EASILY RECOVERED WITHOUT ADDITIONAL MEDICAL INTERVENTION AND THE DOCTOR WAS ABLE TO PROCEED WITH THE PROCEDURE BY OPENING ANOTHER STERILE 2.65 MM DRILL KIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR A SPEED SHIFT/TITAN DRILL KIT S-265QD. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7641681 ↗MalfunctionMar 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT DURING A SURGERY FOR TARSOMETATARSAL FUSION ON (B)(6) 2018 A SPEED COMPRESSION IMPLANT KIT 18X15X15MM WAS NOT GETTING DISLODGED FROM THE INSERTER. THE SURGERY WAS COMPLETED USING ANOTHER AVAILABLE KIT. THERE WAS NO REPORTED SURGICAL DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7384305 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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