MAUDE Adverse Event Report: IN2BONES SAS I.B.S SCREW; I.B.S 2.5-C COMPRESSION SCREW - DIAM 2.5MM LG20MM

Model Number S25 ST020

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Event Description

The i.B.S.Compression and neutralization osteosynthesis screws are intended for: -the fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs; - osteosynthesis requiring a mono or bicortical compression.Before screw insertion, the screw head placement shall be prepared thanks to the dedicated starter.Event description, as stated by the complaint initiator: "when placing the screw of the m1 scarf osteotomy (hallux valgus correction), and despite the previous preparation with the starter, i encountered a difficulty to finish the introduction of the screw head in the bone (difficulty worsen by the very good bone quality of the young patient).As the torx imprint did not engage, i thought that the screwdriver imprint was damaged, but it was the imprint of the screw head that was damaged and partially broken (which explains why the screwing could not be finished); it was impossible to remove the screw, i had to saw the screw head part that was protruding from the first metatarsal bone.Clinical consequences observed: the patient being under loco-regional anesthesia, she heard and understood the difficulties.I post-operatively gave her the following explanations: no consequences expected for the upcoming bony consolidation.But difficulty or impossibility to remove the screw if required at a later date".The surgery ended successfully without any consequences for the patient.However, it is considered that if the event were to happen again it could cause a serious injury to the patient and is thus to be reported.

Manufacturer Narrative

Batch record (in2bones batch number 2010009) was reviewed and found to be compliant.The products were released on november 2020.This event is the first complaint involving an implant of this batch.A global review of all complaints related to i.B.S compression and neutralization screws reported with a damaged head and / or torx imprint was performed.Since the initial marketing of the range in 2012, 6 screws were reported with a damaged head and / or torx imprint for 173 419 screws sold worldwide.The failure rate is thus estimated to (b)(4), and the severity corresponding to the complaint is "moderate".The resulting health risk index (hri) score is deemed acceptable as per in2bones internal hri evaluation procedure (sop par04).The device was not returned to in2bones since it remained implanted.However, based on the circumstances and information provided by the complaint initiator, it can be assumed that this event is related to the use conditions and mainly to the patient bone quality.

• Brand Name: I.B.S SCREW
• Type of Device: I.B.S 2.5-C COMPRESSION SCREW - DIAM 2.5MM LG20MM
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 11419847
• MDR Text Key: 280447300
• Report Number: 3010470577-2021-02141
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K131920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S25 ST020
• Device Lot Number: 2010009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 60