MAUDE Adverse Event Report: SMITH & NEPHEW, INC. XTENDOBUTTON ROUND MD17 DIA 7.5 PEG; RETENTION DEVICE, SUTURE

Model Number	71935602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to infection.The subject had an acl tear that was repaired using the xtendobutton, back in (b)(6) 2019.Later on, the patient presented an infection which was treated with arthroscopic washout and synovectomy as well as antibiotic therapy via picc line; the device remained in situ.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h6 the reported xtendobutton, used in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the patient presented an infection, ergo, a light growth of staphylococcus capitis grown in blood culture bottles was required.Resulting in a washout and synovectomy as well as antibiotic therapy using vancomycin via picc line; the device remained in situ.An exact root cause cannot be determined with confidence.

• Brand Name: XTENDOBUTTON ROUND MD17 DIA 7.5 PEG
• Common Device Name: RETENTION DEVICE, SUTURE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10099580
• Report Number: 1219602-2020-00823
• Device Sequence Number: 3441184
• Product Code: KGS
• UDI-Device Identifier: 00885556702703
• UDI-Public: 00885556702703
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: Health Professional
• Device Model Number: 71935602
• Device Catalogue Number: 71935602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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; Required Intervention