MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIRAPTR 2.9 AB SUTR ANCR TWO 38 U/B; SCREW, FIXATION, BONE

Catalog Number 72201702

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

Foreign zipcode.

Event Description

It was reported that, after using a bioraptor suture anchor for a primary lateral ligament reconstruction of an ankle ((b)(6) 2019), the patient developed secondary sepsis.On (b)(6) 2019, the anchor had to be removed due to inflammation and pain.Although no pathogen was identified in the infection site, the patient was treated with washout of wound and intravenous antibiotics.The patient's outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported 2.9 bioraptor ab anchor assembly, intended for use in treatment, will not be returned for evaluation.Due to the nature of the complaint a review of the sterility records for the lot number in question was performed which confirmed that the product was sterilized per the standard terminal sterilization process.All parameters of the sterilization cycle conformed to the validated parameters (see attachment).Without supporting clinical documentation and given the manufacturing records confirmed sterility conformance, a mal-performance of the implant could not be supported and the root cause of the s.A.Infection could not be definitively determined.Extrinsic factors, latent infection and/or hematogenous spread could not be ruled out as possibly contributing to the reported infection/secondary sepsis.The patient impact beyond the reported symptoms, secondary sepsis and subsequent therapies/surgical procedures could not be determined, as the patient outcome was reportedly ¿unknown¿.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BIRAPTR 2.9 AB SUTR ANCR TWO 38 U/B
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9302890
• MDR Text Key: 166057479
• Report Number: 1219602-2019-01414
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010607553
• UDI-Public: 03596010607553
• Combination Product (y/n): N
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Catalogue Number: 72201702
• Device Lot Number: 50780050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR