MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG BONE WAX; WAX,BONE

Model Number	BW25G
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Codes	Hematoma (1884); No Code Available (3191)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the product had a bad texture and bad support in the bone with difficult use, resulting to an absence of haemostatic effect.Another surgery had been necessary to resolve the case.The patient is alive.No additional information was provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during spin surgery, the product had a bad texture and bad support in the bone with difficult use, resulting to an absence of haemostatic effect.There was an appearance of a hematoma and another surgery had been necessary to resolve the case.The patient is alive.No additional information was provided the current patient status is ok.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A review of the manufacturing and quality records for this lot found no reports relating to dry or crumbling product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: BONE WAX
• Common Device Name: WAX,BONE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6661905
• Report Number: 1219930-2017-05853
• Device Sequence Number: 197677
• Product Code: MTJ
• UDI-Device Identifier: 20884521196268
• UDI-Public: 20884521196268
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K024372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: BW25G
• Device Catalogue Number: BW25G
• Device Lot Number: 16041458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 12/05/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/26/2017; 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention