MAUDE Adverse Event Report: BIOCOMPOSITES LTD BIOSTEON; BIOSTEON SCREW

Model Number BS190914

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

All biosteon screw devices are manufactured by biocomposites ltd for stryker.The reported event was only forwarded to stryker recently, who then forwarded it to biocomposites ltd on 23 feb 2024 as the legal manufacturer.The reported product was manufactured in 2019, with the event and product's expiration date being in 2022.

Event Description

On (b)(6) 2022 she underwent an arthroscopic acl reconstruction and partial lateral meniscectomy where a biosteon 35 x 10mm interference screw was used.Subsequently the patient developed pain for several months, it was discovered that the screw allegedly fractured and had to be removed on (b)(6) 2022.Tibial tunnel was created utilizing a 9 mm reamer.7-mm offset guide was then aced in the tibial tunnel and a second guide pin was placed 7 mm anterior to over-the-top position in the 2:30 position on the roof.Femoral tunnel was drilled to a depth of 30 mm.The screw was removed in second surgery after months of pain on (b)(6) 2022.This is a 45-year-old female status post left knee acl reconstruction done 4 months ago.She has continued to have anterior knee pain and difficulty with extension.An mri was obtained, which demonstrates failure of the hardware with partial or complete graft failure.She now presents for operative intervention.Plan is to remove the screw and then assess the graft.If the graft does not need to be revised, it will be left alone.If the graft is damaged, the plan would be to either do 1 or 2-stage revision.Screw broke inside patient body and was later removed.Final procedures: 1.Left knee open curettage and debridement of tibial bone tunnel with placement of allograft bone dowels.2.Left knee arthroscopic debridement of acl graft with debridement of tunnels and abrasion chondroplasty of medial tibial plateau.

• Brand Name: BIOSTEON
• Type of Device: BIOSTEON SCREW
• Manufacturer (Section D): BIOCOMPOSITES LTD; ic4; keele; stoke-on-trent, staffordshire ST55N L; UK ST55NL
• Manufacturer (Section G): BIOCOMPOSITES LTD; ic4; keele; stoke-on-trent, staffordshire ST55N L; UK ST55NL
• Manufacturer Contact: kirsty-louise marror ; ic4; keele; stoke-on-trent, staffordshire ST55N-L ; UK ST55NL
• MDR Report Key: 18894260
• MDR Text Key: 337547168
• Report Number: 9617083-2024-00003
• Device Sequence Number: 1
• Product Code: MBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/30/2022
• Device Model Number: BS190914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2019
• 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): Hospitalization
• Patient Age: 44 YR
• Patient Sex: Female