XTENDOBUTTON ROUND MD17 DIA 7.5 PEG
Received May 28, 2020 · Event occurred Oct 10, 2019
Report 1219602-2020-00823 · MDR key 10099580
Device
Generic name
Retention Device, Suture
Manufacturer
Smith & Nephew, Inc.Model number
71935602Catalog number
71935602
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Description of Event or Problem
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.