MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SURGICAL SPECIALTIES; BONE WAX

Model Number 903B

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history record, manufacturing records, sterility records, incoming inspection of raw material components, in-process and final inspection process.No non-conformities were identified.No changes were made to the formulation, processes or packaging.The product is sold to cardinal health as a sterile product, bulk device.No photos were provided of the surgical site or of the device used.No sterile devices from lot aaeg160, aagf768 were returned for testing/review.According to ifu p/n: 03-5125 r5 for bone wax 903b: under ¿directions and dosage¿ section: use bone wax immediately after removal from the package.Using aseptic technique, take 1 to 1.5 grams of bone wax, manipulate with the fingers to soften, and apply to bone surface.Optimum working temperature 70°- 74° f ( 21°- 23°c).Under ¿storage¿ section: recommended storage conditions: below 77° f (25 °c), away from moisture and direct heat.Samples from a different lot reported for a similar adverse case ((b)(4)) were received from the same facility for review/testing.The sterile samples were manipulated per the instructions in the ifu.The wax became warm, malleable and easily adhered to a hard surface.The wax device was similar to putty, no signs of flakes or crumbling was observed.Without receiving additional details regarding the patient's health history, procedure performed, method utilized to manipulate and utilize the bone wax and/or the surgeon's technique, a definitive root cause cannot be determined at this time.

Event Description

Patient had initial surgery (b)(6) 2020 where bone wax ( from cardinal health craniotomy pack) was used to repair the csf leak.Patient came back for surgery on (b)(6) 2021 to repair csf leak with the bone wax; patient again return to or on (b)(6) 2021 to repair the csf leak with bone wax from a different manufacturer.The bone wax was identified as being flaky, brittle, and did not provide an adequate seal.Bone wax used during surgery on (b)(6) 2021: surgical specialties bone wax, ref 903, lot#aagf768.Bone wax used during surgery on (b)(6) 2020: surgical specialties bone wax, ref 903, lot# aaeg160.

• Brand Name: SURGICAL SPECIALTIES
• Type of Device: BONE WAX
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 11676432
• MDR Text Key: 257144684
• Report Number: 3010692967-2021-00014
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050292
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2021,04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 903B
• Device Lot Number: AAGF768
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/29/2021
• Device Age: 30 MO
• Event Location: Home
• Date Report to Manufacturer: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention