BIOSYNC ANATOMIC COTTON WEDGE, 20X7.5 MM
Received Sep 19, 2022 · Event occurred Aug 19, 2022
Report 1220246-2022-05499 · MDR key 15445778
Device
Generic name
Bone Wedge
Manufacturer
Arthrex, Inc.Model number
BIOSYNC ANATOMIC COTTON WEDGE, 20X7.5 MMCatalog number
AR-8948W-2075
Product problems
- Break
- Entrapment of Device
Patient
Unknown
- Foreign Body In Patient
- Device Embedded In Tissue or Plaque
- Foreign Body In Patient
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED ON 09/01/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8948W-2075 BIOSYNC WEDGE BROKE IN THE PATIENT REQUIRING A REVISION SURGERY TO REMOVE.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER PROVIDED PHOTO, WHICH DISPLAYS THE BROKEN WEDGE. HOWEVER, WITHOUT RETURN OF THE DEVICE FOR PHYSICAL EVALUATION, THE CAUSE REMAINS UNDETERMINED. NO CHANGE IN HARM WAS IDENTIFIED.