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

Model Number	3910-200-083
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SUTURE ANCHOR
• Manufacturer (Section D): BIOCOMPOSITES LTD.; keele science park; ic4; keele, keele ST5 5 NL; UK ST5 5NL
• MDR Report Key: 10565786
• Report Number: 9617083-2020-00001
• Device Sequence Number: 19137322
• Product Code: LOE
• UDI-Device Identifier: 15060155711185
• UDI-Public: 15060155711185
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1