MAUDE Adverse Event Report: IN2BONES SAS I.B.S SCREW; I.B.S® 3.5-C COMPRESSION SCREW - DIAM 3.5MM LG32MM, PRODUCT

Model Number	S35 ST132
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Screws: batch records was reviewed and found to be compliant.The product was released on december 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 broken screw (all breakages types in the forefoot area) was performed.Since the initial marketing of the range in 2012, 15 screws were reported broken when used in the forefoot for (b)(4) screws sold worldwide (up to may 1st,2023).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 was discarded.Should any other information arise, in2bones will update this report.
Event or Problem Description
The i.B.S.¿ compression and neutralization osteosynthesis screws are used in forefoot ortthopaedic surgery and 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 : initial information reported by a distributor on (b)(6), 2022: "they realized that the screw location was too dorsal and looked bent as well on x-ray.Once they got the screw out, the bottom of screw broke off.I added images that i took that day of the driver that broke, the screw once it came out, and the x-ray of ibs screws when first implanted.Surgeon ended up using two 4.0 screws to complete the case (after taking out ibs screws) and was content with screw placement." the surgery ended successfully after a significant delay in surgery duration; any consequences for the patient.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.

• Brand Name: I.B.S SCREW
• Common Device Name: I.B.S® 3.5-C COMPRESSION SCREW - DIAM 3.5MM LG32MM, PRODUCT
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully 69130, france, ; FR
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully 69130, france ; FR
• Manufacturer Contact: sabina ahaddad ; 28 chemin du petit bois; batiment 2; ecully 69130, france ; FR
• MDR Report Key: 17754723
• Report Number: 3010470577-2022-11161
• Device Sequence Number: 7094019
• Product Code: HWC
• UDI-Device Identifier: 03760225711811
• UDI-Public: 03760225711811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2023

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: 10/21/2025
• Device Model Number: S35 ST132
• Device Lot Number: 2011038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown