MAUDE Adverse Event Report: IN2BONES SAS I.B.S SCREW; I.B.S COMPRESSION SCREW (2.5MM DIAMETER, 24MM LENGTH)

Model Number	S25 ST024
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch record 1907223 was reviewed and found to be compliant.Upon inspection of the part, which was returned to in2bones, it appears that the screw body is twisted and that its distal part is broken.The distal part of the screw which broke during the surgery was left implanted, without any negative outcomes for the patient.The surgery ended successfully without consequences for the patient.The occurrence for this type of incident is estimated to (b)(4): for 23 517 ibs 2.5mm compression screws sold worldwide, 14 were reported to be twisted and / or broken (sales data extracted on (b)(6), 2020).This failure rate is deemed acceptable.Considering this acceptable failure rate, the absence of patient consequences, and the incident root cause no field action is deemed necessary.In2bones will continue to closely monitor this type of incident and will trigger a field action if the occurrence and / or adverse health outcome increase to an unacceptable level.The main hypothesis would be that the event is related to the patient bone quality (i.E.Patient having hard bones) and / or to an incorrect use.
Event or Problem Description
The i.B.S(r) 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.Event description: an i.B.S compression screw is reported to have broken during a bunion surgery (i.E.Correction of an hallux valgus).Despite the reported problem, the surgery ended successfully without any consequences for the patient.

• Brand Name: I.B.S SCREW
• Common Device Name: I.B.S COMPRESSION SCREW (2.5MM DIAMETER, 24MM LENGTH)
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 10827446
• Report Number: 3010470577-2020-02071
• Device Sequence Number: 3254099
• Product Code: HWC
• UDI-Device Identifier: 03760225710159
• UDI-Public: 03760225710159
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: S25 ST024
• Device Lot Number: 1907223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1