MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT

Catalog Number 61910002

Device Problems Use of Device Problem (1670); Device Contamination with Chemical or Other Material (2944); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.Additional information has been requested but not provided due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported that the surgeon noticed the brown particle from the cement during mixing the cement.Spare product was used instead of it and the procedure was completed.

Manufacturer Narrative

An event regarding foreign matter in the cement mix involving simplex p bone cement was reported.The event was confirmed.Method & results: -device evaluation and results: organic analysis concluded that the (two) particles were found to be the same in nature and coated with a hard white ¿bubbly¿ material which was found to be a poly(methyl methacrylate) and is likely to be a bone cement.The foreign material itself was found to be a glass material with a zinc oxide coating.-medical records received and evaluation: not performed as no medical records were provided and no adverse consequences to the patient were reported.-device history review: review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.-complaint history review: complaint history review determined that there were no other reported similar events for this lot.Conclusions: the organic analysis concluded that the foreign matter was glass and that it was surrounded by poly(methyl methacrylate), likely to be a bone cement.Instructions are provided in the ifu: do not open the ampoule over the mixing container.Pieces of glass may fall into the container and get intermixed with the bone cement.No further investigation is required at this time.

Event Description

It was reported that the surgeon noticed the brown particle from the cement during mixing the cement.Spare product was used instead of it and the procedure was completed.

• Brand Name: SIMPLEX P-JAPANESE TWIN PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick 00000
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5141343
• MDR Text Key: 28329521
• Report Number: 0002249697-2015-03299
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/11/2015

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: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 61910002
• Device Lot Number: JFW020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2015
• 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 Outcome(s): Other