DynaFORCE™ 7115-1515KTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815432023325), received between Dec 3, 2019 and Oct 14, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K142727, K181410); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Fracture; Fracture

  DOCTOR MENTIONED THAT HE HAD A CASE IN WHICH SOME OF THE HARDWARE EXPERIENCED MECHANICAL FAILURE. THE DISCOVERY DATE OF THE HARDWARE IS UNKNOWN. AN EMAIL WAS SENT TO THE SURGICAL REPRESENTATIVE TO FIND OUT MORE INFORMATION REGARDING THE FAILURE. AN X-RAY WAS OBTAINED AND WILL BE INCLUDED IN THE COMPLAINT FILE. THE X-RAY DEPICTS WHAT APPEARS TO BE A BROKEN HIMAX IMPLANT ALONG WITH 2 BROKEN SCREWS. THE ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2018. THE HARDWARE WAS NOT REMOVED OR REVISED AND THERE ARE NO PLANS TO REVISE THE SITE. PER THE SALES REP, DOCTOR IS SATISFIED WITH THE OUTCOME OF THE CASE AND THE STATUS OF THE UNION. REP ALSO MENTIONED THAT THE PATIENT WAS NON-COMPLIANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606518 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  DOCTOR REPORTS THAT ON (B)(6) 2019 HE PERFORMED A 1ST, 2ND, AND 3RD TARSO-METATARSAL FUSION SURGERY USING CROSSROADS STAPLES FOR THE 2ND AND 3RD TMT FUSIONS. HE SAYS THAT AT SOME POINT POST-SURGERY THE PROXIMAL STAPLE LEG IN THE 3RD TMT JOINT BROKE. DOCTOR REPORTS THAT THE PATIENT IS A SMOKER AND IS ALSO NON-COMPLIANT WITH REGARDS TO WEIGHTBEARING. HOWEVER, HE SAYS ON THE OBLIQUE X-RAY PROVIDED THAT THE JOINTS APPEAR TO BE HEALING WELL AND FUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501686 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  THIS COMPLAINT WAS RECEIVED BY MAIL THROUGH AN FDA MEDICAL DEVICE REPORT (MDR) THAT WAS WRITTEN BY A PATIENT. ALLEGEDLY, THE PATIENT STATES THAT THEY HAVE A DEFECTIVE AND BROKEN CLIP THAT HAS CAUSED LIMPING, BACK MISALIGNMENT AND KNEE PAIN. THE PATIENT IS CONVINCED THE CLIP WAS BROKEN AND DEFECTIVE AT THE TIME OF IMPLANTATION, ACCORDING TO THE REPORT (MW5086568).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501680 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  REP REPORTS THAT DOCTOR PERFORMED A 2ND AND 3RD TMT FUSION CASE WITH 4 CLIPS. UPON FOLLOW-UP POST-PROCEDURE, THE MOST MEDIAL CLIP ON THE 2ND TMT FUSION APPEARED BROKEN ON X-RAY WHICH WAS ONE OF THE THREE 18MM X 18MM HIMAX IMPLANTS USED IN THE CASE. REP REPORTS THAT THE PATIENT IS DOING FINE AND THE JOINT HAS EXPERIENCED PROPER FUSION. NO REVISION SURGERY IS PLANNED TO DATE. NO RESOLUTION. PATIENT IS REPORTED TO BE DOING OKAY AND JOINT IS PROPERLY FUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501585 ↗
• InjuryDec 3, 2019Fracture; Fracture

  DURING AN UNRELATED TOTAL ANKLE ARTHROPLASTY, THE DOCTOR IDENTIFIED A BROKEN MOTOCLIP IMPLANT. MOTOCLIP IMPLANT WAS REMOVED AFTER THE TAA WAS COMPLETE. THE DOCTOR CONFIRMED THAT AN ADDITIONAL SURGERY TO REVISE OR REMOVE THE IMPLANT WOULD NOT HAVE BEEN SCHEDULED PROACTIVELY SEPERATE FROM THE TAA.

  Patient problems: Failure of Implant

  MAUDE report 9406312 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142727, K181410. One submission often covers many models, so check the product and lot details in each record.

• Z-1487-2017 · Feb 16, 2017 · Terminated
  MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.