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

Catalog Number 61910001

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the batch manufacturing records indicates the twin packs were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.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.

Event Description

It was reported that, during a tha, when a surgeon picked the inner pouch from outer pouch, he found a black material between the inner and outer.

Manufacturer Narrative

An event regarding foreign matter involving a simplex powder pouch was reported.The event was confirmed.Method & results: device evaluation and results: the mar indicated: foreign particles reported in surgical simplex p radiopaque bone cement outer pouch from lot 576mx1 was confirmed as brown particle approximately 1mm in length.The foreign particle was observed in the outer pouch seal interface with tyvek.Medical records received and evaluation: not performed as no medical records were provided.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the mar indicated: foreign particles reported in surgical simplex p radiopaque bone cement outer pouch from lot 576mx1 was confirmed as brown particle approximately 1mm in length.The foreign particle was observed in the outer pouch seal interface with tyvek.A memo was submitted by the simplex quality engineer.It states: based on investigation completed it is unlikely that foreign material noted arises from the process, however the constraint of not having an identification and origin of the material inhabited any further detailed analysis to be conducted.As a precautionary measure a device defect awareness form has been completed with operators in the powder pouch fill cleanroom to communicate event.No further investigation is possible 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 tha, when a surgeon picked the inner pouch from outer pouch, he found a black material between the inner and outer.

• 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: 6841689
• MDR Text Key: 84646581
• Report Number: 0002249697-2017-02668
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• 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