MAUDE Adverse Event Report: BIOCOMPOSITES LTD. BIOSTEON INTRALINE; SUTURE ANCHOR

Model Number 3910-200-083

Device Problem Inaccurate Information (4051)

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

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

The following devices were shipped to stryker in (b)(6) with missing contraindication section in the instructions for use.Commercial name/brand: biosteon intraline 5.5mm anchor, needles, two #2 force fiber.Biosteon intraline 5.5mm anchor, three #2 force fiber.Biosteon intraline 6.5mm anchor, three #2 force fiber.Lot/batch numbers: bi200709, bi200710.Model numbers: 3910-200-082 - quantity shipped: x18 packs - total of x90 devices, x5 per pack.3910-200-083 - quantity shipped x6 packs - total of x30 devices, x5 per pack 3910-200-086 - quantity shipped x10 packs - total of x50 devices, x5 per pack.Recall reason: instructions for use (ifu) are missing contraindications section.Planned action: products affected to be returned to biocomposites ltd.For reworking to add amended instructions for use.

Event Description

Biosteon intraline devices left the manufacturing site with key information missing from the instructions for use.Contraindications were missing from latest revision (revision e) during update of the instructions for use, the contraindications section was missing.

• Brand Name: BIOSTEON INTRALINE
• Type of Device: SUTURE ANCHOR
• Manufacturer (Section D): BIOCOMPOSITES LTD.; keele science park; ic4; keele, keele ST5 5 NL; UK ST5 5NL
• Manufacturer (Section G): BIOCOMPOSITES LTD.; keele science park; ic4; keele, keele ST5 5 NL; UK ST5 5NL
• Manufacturer Contact: lyle robertson ; keele science park; ic4; keele, keele ST5 5-NL ; UK ST5 5NL
• MDR Report Key: 10565786
• MDR Text Key: 245066193
• Report Number: 9617083-2020-00001
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 15060155711185
• UDI-Public: 15060155711185
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/22/2020

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 Operator: No Information
• Device Expiration Date: 07/31/2022
• Device Model Number: 3910-200-083
• Device Catalogue Number: 3910-200-083
• Device Lot Number: BS200709/710
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1