MAUDE Adverse Event Report: MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. DBX; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number 227005

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

Event Description

Total hip arthroplasty: surgeon requested 4 of mft biologics aft straight tube (ref: (b)(4)) be opened to the field.With two of them, the surgeon could not get the product out of the tube.He asked for more and we had no more of the straight tubes and had to open a diverted tube (ref: (b)(4)).The diverted one did not work either.I took the diverted tube and two straight tubes off the field and made sure they were wasted in the patient chart.I put the diverted tube back in its package but was not able to know what packages correlated with the two faulty straight tubes.This report includes 1 aft diverted tube (3/4 filled) and its details and 2 aft straight tube (1/2 filled) with only limited details on 2nd package (tube was saved but box not saved).

• Brand Name: DBX
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC.; 125 may street; edison NJ 08837
• MDR Report Key: 9665340
• MDR Text Key: 177634530
• Report Number: 9665340
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/03/2019,12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 227005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Weight: 90