MAUDE Adverse Event Report: . OPTIPAC 60 REFOB BONE CMT R-3; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

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

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the cement would not adhere to the bone but stuck to surgical gloves, did not reach the appropriate temperature, and took longer to harden than normal.No patient consequences or additional information were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Reserve sample from the same lot was evaluated and the reported event was unconfirmed.Testing was performed under standardized conditions and the sample tested showed the product is conformed.Device history record ( dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined at this tim.A summary of the investigation has been sent to the complainant.According to the available data, no non-conformity has been detected.If any further information is found which would changer any conclusions or information, a supplemental will be filled accordingly.

• Brand Name: OPTIPAC 60 REFOB BONE CMT R-3
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): .; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: helene bataille ; plateau de lautagne bp75; valence, IN 26903 ; FR 26903 ; 5745273773
• MDR Report Key: 7099581
• MDR Text Key: 94933195
• Report Number: 3006946279-2017-00279
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 4711500396-3
• Device Lot Number: 636AA05135
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1