MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX TOBRAMYCIN 1 PK; BONE CEMENT

Catalog Number 61971001

Device Problems Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

Glass fragment from simplex cement monomer vial found in mixed bone cement during total knee replacement.

Manufacturer Narrative

An event regarding glass fragments found in simplex cement mix was reported.The event was not confirmed.Method & results: -device evaluation and results: two empty ampules were returned.Photographs were provided.One of the photographs provided shows a small brown substance/particle embedded in what appears to be hardened bone cement.Two empty ampoules are also visible from the photographs, no unusual characteristics were observed from the photographs, the plastic covers/crackers were present on the top of the ampoules.-medical records received and evaluation: not performed as no medical records were provided.-device history review: the product was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: an event regarding alleged glass fragment from simplex cement monomer vial found in mixed bone cement could not be confirmed.Foreign matter can be observed in the cement mix attached in the photograph provided by the customer.However only the empty ampules were returned, as the sample containing the cement mix was then discarded by the customer no material analysis of the foreign matter could be performed.Further information is required to complete this investigation and determine a root cause.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.Reported fm not returned.

Event Description

Glass fragment from simplex cement monomer vial found in mixed bone cement during total knee replacement.

• Brand Name: SIMPLEX TOBRAMYCIN 1 PK
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6321723
• MDR Text Key: 67442266
• Report Number: 0002249697-2017-00520
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 61971001
• Device Lot Number: TFW032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2015
• 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