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

Model Number 903B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 03/03/2021

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.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 this lot were returned from the 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 surgery on (b)(6) 2021 where bone wax was used with gelfoam for surgery packing.Patient presented to emergency department (b)(6) 2021 and underwent surgery to repair csf leak.

Event Description

Patient had surgery (craniotomy for excision of tumour) on (b)(6) 2021 where bone wax was used with gelfoam for surgery packing.Patient presented to emergency department (b)(6) 2021 and underwent surgery to repair csf leak.Ahs mdip reference number (id): (b)(4).

Manufacturer Narrative

No photos were provided of the surgical site/wound or of the device used.Four (4) samples were returned from alberta health services/foothills medical centre for review.The devices were contained within a ziplock bag, one (1) device was already opened, three (3) samples remained sealed, sterile.All returned samples were labeled as lot aagi410 (see picture 1).The non sterile, opened sample was stained with what appeared to be blood on the outside of the pouch, however upon examining the bonewax ingot within, the wax displayed no signs of manipulation; the wax remained in the original state.It is noted the non sterile sample was returned in no special packaging; the bonewax was exposed (see picture 2).One (1) of the sterile samples was opened and manipulated by a quality engineer per the ifu (instructions for use) provided with the bonewax device: taken from ifu p/n: 03-5125 r5 for bonewax 903b: under ¿directions and dosage¿ section: use bonewax 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.Temperature and humidity were noted (with a calibrated equipment) before proceeding to knead the bonewax with a temperature reading oscillating between 22.7 °c and 23.5 36.9 %rh.Upon proceeding to knead the bonewax, no crumbliness was observed and the texture of the bonewax was akin to putty.Easily malleable and able to sustain its form (see picture 3).The remaining samples will be kept stored until further testing is required.Without receiving details regarding the preoperative preparation of the device(s), procedure performed, post-operative events that may have attributed in the patient requiring an additional procedure/surgical intervention or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• 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
• MDR Report Key: 11676483
• MDR Text Key: 257144056
• Report Number: 3010692967-2021-00015
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): Y
• PMA/PMN Number: K050292
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/15/2021,04/21/2021

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 Model Number: 903B
• Device Catalogue Number: 903B
• Device Lot Number: AAGI410
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2021
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1