MAUDE Adverse Event Report: INION OY INION FREEDOMPIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Objective of this study / publication was to investigate the clinical and radiological outcome of the lesser toe deformities or fractures operated by interphalangeal joint fusion using biodegradable pins (inion freedompin) as fixation.Consecutive patients operated by proximal (pipj) or distal interphalangeal joint (dipj) arthrodesis using the inion freedompin with a minimum of 12 months of follow-up were retrospectively evaluated both clinically and radiologically.21 patients with 24 feet and 31 toes were available with median follow-up time of 26 (range 12-40) months.The clinical evaluation included alignment, swelling and pain of the operated toes, stability of the fused joints, congruence of the mtp joints, complications, revisions, and a subjective patient satisfaction.The radiographic evaluation included weight-bearing dorso-plantar, oblique, and lateral views of the operated foot for the analysis of the alignment, bony union, implant related bony reactions and other radiological complications.One patient (diagnosis: hammer toe) had non-optimal alignment and non-fusion of the osteotomy line in one of the operated toes.This patient had 4 toe repairs done in the same procedure, including this non-union on the pinky toe and the non-repair of the toe line at follow-up (25 months follow-up time).This might lead to a need for a secondary intervention at a later stage, although this study reported that the patient currently had no symptoms.

Manufacturer Narrative

Objective of this study / publication was to investigate the clinical and radiological outcome of the lesser toe deformities or fractures operated by interphalangeal joint fusion using biodegradable pins (inion freedompin) as fixation.One patient (diagnosis: hammer toe) had non-optimal alignment and non-fusion of the osteotomy line in one of the operated toes.This was considered reportable due to possibility that this might lead to a need for a secondary intervention at a later stage, although this study reported that the patient currently had no symptoms.This patient had 4 toe repairs done in the same procedure, including this non-union on the pinky toe and the non-repair of the toe line at follow-up.The other toes (i.E.Toes ii-iv) were completely ossified, of which two have fully corrected the alignment (toes iii and iv), one toe (toe ii) has partial alignment.The authors state that this patient was diagnosed with unspecific neuropathy soon after the operation and was later suspected to have charcot neuroarthropathy, which probably explains the recurrence of the deformity.This patient condition is the probable reason for the non-fusion and non-optimal alignment and the study did not report that the used inion freedompin would have caused or contributed the recurrence of the deformity.In all 21 patients with 31 operated toes there were no postoperative complications and revision surgeries or secondary medical intervention was not required.All toes were clinically asymptomatic and the clinical alignment of the operated toe was good in all but one toe mentioned above.Radiologically the toe alignment was corrected in 25, partially corrected in 5, and not corrected in 1 toe.A complete radiological bony fusion was detected in 25 (81%), partial in 1 (3%), and no fusion in 5 (16%) toes.One small osteolytic lesion was detected radiologically in one toe at 19 months follow-up.However, this patient had no symptoms.All radiological findings in this study were asymptomatic and required no medical treatment or additional interventions.All patients were reported to be satisfied and would have chosen the same operation again.The freedompin bioabsorbable pin was clinically and radiologically concluded to be safe and reliable method for lesser toe pipj or dipj arthrodesis.

• Brand Name: INION FREEDOMPIN
• Type of Device: PIN
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer (Section G): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer Contact: kati marttinen ; lääkärinkatu 2; tampere, 33520 ; FI 33520
• MDR Report Key: 17245372
• MDR Text Key: 318281169
• Report Number: 3003407235-2023-00004
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K133932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic