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 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Customer reported to have noticed a hair in the packaging of simplex p.

Manufacturer Narrative

An event regarding foreign matter found in the powder pouch involving simplex bone cement was reported.The event was confirmed through visual inspection.Method & results: device evaluation and results: a material analysis has been performed.The report concluded: characterisation of complaint foreign material using stereo microscopy and electron microscopy identified foreign material as biological hair fragment.Medical records received and evaluation: not performed as no medical records were provided.Device history review: indicated: indicated product were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot referenced.Conclusions: an event regarding foreign material was found in the packaging of simplex p bone cement powder.A material analysis has been performed.The report concluded: characterisation of complaint foreign material using stereo microscopy and electron microscopy identified foreign material as biological hair fragment.Nc was raised on (b)(6) 2017 for foreign matter on simplex powder pouch and concluded that current controls to prevent foreign material of biological hair in powder pouch are deemed sufficient as this was found to be an isolated event.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

Customer reported to have noticed a hair in the packaging of simplex p.

• 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: 7026266
• MDR Text Key: 92768819
• Report Number: 0002249697-2017-03280
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 61910001
• Device Lot Number: CFY063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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