MAUDE Adverse Event Report: OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number 60MA4

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.The distortion of the disc used for trimming probably caused microcracks in this product.Because this product which was implanted(referenced in this report) was not returned to olympus terumo biomaterials corp.For evaluation, the cause of the event has not been specified.Warning and precaution: important basic precautions: when load bearing capacity has been weakened or reduced due to fractures, etc., osferion should only be used if the bone can be reliably immobilized by using external or internal fixations etc.Otherwise, compaction of fractures may occur.If necessary, the fracture should be stabilized using external or internal fixations to prevent post-implantation migration or extrusion of the osferion due to loosening.Cutting wedge or trapezoids may cause cracking or inappropriate breaking, etc.This report is being submitted as a medical device report is an abundance of caution.

Event Description

A surgeon carried out medial opening-wedge proximal low tibial osteotomy.During the surgery, the surgeon trimmed this product (bone void filler) and inserted it into the posterior part of the bone defect formed after osteotomy.However, the product cracked longitudinally.The surgeon trimmed the product again and carefully placed it into the bone defect, but the product cracked again.With a judgement that the cracked product would cause no problem, the surgeon left the product as it was and continued the surgery.The surgery ended without problems other than the above-mentioned event.

• Brand Name: OSFERION
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY; 454-1 higashino,nagaizumi-cho; sunto-gun; shizuoka, 411-0 931; JA 411-0931
• Manufacturer (Section G): OLYMPUS TERUMO BIOMATERIALS CORP.; 1-50-1 sasazuka,shibuya-ku; tokyo, 151-0 073; JA 151-0073
• Manufacturer Contact: jiro hirai ; 1-50-1 sasazuka,shibuya-ku; tokyo, 151-0-073 ; JA 151-0073
• MDR Report Key: 11137434
• MDR Text Key: 262706877
• Report Number: 3007738819-2021-00001
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60MA4
• Device Lot Number: 20607C880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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 Age: 44 YR
• Patient Weight: 72