inforMED
MalfunctionHTT

BRASSELER

Received Mar 4, 2011 · Event occurred Feb 23, 2011

Report 2024516 · MDR key 2024516

Device

Generic name

Round Steel Bur

Model number

*

Catalog number

16-S0113

Lot number

NAOLN

Product problems

  • Break
  • Entrapment of Device
  • Difficult to Remove

Patient

86 YR

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

PATIENT WAS TAKEN TO SURGERY FOR REVISION OF THE HEAD OF A PROXIMAL HUMERAL COMPONENT WITH REPAIR OF FRACTURES OF THE GREATER AND LESSER TUBEROSITIES. PATIENT HAS BEEN SUFFERING FROM A FRACTURED AND DISLOCATED PROXIMAL HUMERUS. UPON USING THE BRASSELER 55MM ROUND STEEL BURR TO DRILL INTO THE PATIENT'S HUMERUS, THE BURR TIP (APPROXIMATELY 1.8MM IN SIZE) BROKE OFF IN THE PATIENT'S BONE AND WAS DETERMINED TO BE UNRETRIEVABLE. SURGEON DID ATTEMPT TO REMOVE THE TIP BUT WAS UNSUCCESSFUL. SURGEON MADE THE DECISION TO LEAVE THE TIP IN THE BONE AND PROCEED WITH COMPLETING THE CASE. THE BURR WAS REMOVED FROM THE SURGICAL FIELD AND SEQUESTERED FOR RISK MANAGEMENT. PROCEDURE WAS FINISHED AND PATIENT WAS SENT TO PACU FOR RECOVERY. SURGEON TO ADDRESS THE RETAINED TIP WITH THE PATIENT AFTER SHE HAS RECOVERED FROM HER PROCEDURE.