MAUDE Adverse Event Report: ETHICON INC. BONE WAX 12 X 2.5GRAMS; WAX, BONE

Catalog Number W31C

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The photo upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent an unknown procedure on unknown date in 2019 and bone wax was used.The bone was hard to form, not soft and blood not getting stopped from bone.Very difficult case.The procedure was delayed 15 minutes.The applied product was removed as much as possible.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).Additional investigation summary: upon visual inspection of the pictures, an opened sample of product code w31c could be observed.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing record evaluation review could not be conducted, because the batch number of the complaint is unknown.

• Brand Name: BONE WAX 12 X 2.5GRAMS
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8869101
• MDR Text Key: 153531609
• Report Number: 2210968-2019-85251
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: W31C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Patient Sequence Number: 1