MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SURGICAL SIMPLEX CEMENT; BONE CEMENT

Catalog Number 61910001

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

It was reported that, during a surgery, when a nurse opened the powder, our sales staff found a foreign material like a small fragment of a cardboard.A spare was used instead.

Manufacturer Narrative

Product code; lot #, expiration date;product available to stryker; returned to manufacturer on; device evaluated by mfg; manufacturing date.An event regarding foreign matter found in the powder pouch involving simplex bone cement was reported.The event was confirmed through visual inspection.The mar concluded that the characterisation of complaint foreign material and material from pouch retain inspection using stero microscopy and infrared spectroscopy identified foreign material as cardboard.Medical records received and evaluation: not performed as no medical records were provided.Indicated: indicated all twin packs were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the reported lot referenced.An event regarding foreign material was found in the packaging of simplex p bone cement powder.The mar concluded that the characterisation of complaint foreign material and material from pouch retain inspection using stero microscopy and infrared spectroscopy identified foreign material as cardboard.Nc was raised for foreign matter on simplex powder pouch.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that, during a surgery, when a nurse opened the powder, our sales staff found a foreign material like a small fragment of a cardboard.A spare was used instead.

• Brand Name: SURGICAL SIMPLEX CEMENT
• 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 NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6903097
• MDR Text Key: 87854743
• Report Number: 0002249697-2017-02878
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 61910001
• Device Lot Number: JAY003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other