MAUDE Adverse Event Report: ETHICON INC. BONE WAX; WAX, BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that there was any deficiency in the bone wax device? were these cases previously reported? (b)(4).

Event Description

It was reported in a journal article that a patient underwent a laminectomy procedure between may 1 and july 31, 2002 and bone was used.The patient developed a ssis.During procedures in which bone wax was used, it was removed from its foil container and softened by either the scrub nurse or the surgeon by massaging it between gloved fingers.Because the use of the wax occurs late in the procedure when the gloves are more likely to be contaminated with organisms, we hypothesize that the wax might be inoculated at this time.Because several different organisms were isolated from these ssis, it is likely that the source of the contamination was the patient¿s own skin flora.The patient received either antibiotic or surgical incision and debridement which was initiated within 3 months of the index surgery.Additional information was requested.

• Brand Name: BONE WAX
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6918895
• MDR Text Key: 88385721
• Report Number: 2210968-2017-70307
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention