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

Catalog Number	72201702
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Foreign zipcode (b)(6).
Event or Problem Description
It was reported that, after using a bioraptor suture anchor for a primary lateral ligament reconstruction of an ankle ((b)(6) 2018), 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 a washout of the 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.
Additional Manufacturer Narrative
Device is not being 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).The risk management documentation was also reviewed and found to contain this failure mode within the risk file , no updates are required.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 devices did not meet product specifications upon release into distribution.In conclusion: 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¿.No further medical assessment could be rendered at this time.

• Brand Name: BIRAPTR 2.9 AB SUTR ANCR TWO 38 U/B
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9302878
• Report Number: 1219602-2019-01412
• Device Sequence Number: 2172167
• Product Code: HWC
• UDI-Device Identifier: 03596010607553
• UDI-Public: 03596010607553
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: Health Professional
• Device Expiration Date: 05/02/2021
• Device Catalogue Number: 72201702
• Device Lot Number: 50730881
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/10/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR