MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - US FULL DOSE 10-PK; BONE CEMENT

Catalog Number 61911010

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

An event regarding packaging damage involving a two simplex 10 packs was reported.The event was confirmed through images provided.Method & results: device evaluation and results: the reported components were not returned however photographs were provided for review.The photographs indicate an outer shipping carton with liquid damage which has caused staining on the inside and outside of the corrugated cardboard.The outer packaging of the ten-pack is also stained as a result of liquid damage.It is also reported that upon arrival "there was a strong odor" which is indicative of a recent liquid ampoule breakage.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: indicates all ten packs were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there has been no other similar events for the lot referenced.Conclusions: the reported components were not returned however photographs were provided for review.The photographs indicate an outer shipping carton with liquid damage which has caused staining on the inside and outside of the corrugated cardboard.The outer packaging of the ten-pack is also stained as a result of liquid damage.It is also reported that upon arrival "there was a strong odor" which is indicative of a recent liquid ampoule breakage.Based on the information provided, it appears that this product was damaged due to inappropriate handling during distribution/transportation.The odour from the liquid monomer lasts a short period of time as the liquid evaporates when exposed to the atmosphere.No further investigation is possible at this time as no product and insufficient information was received by stryker orthopaedics.If product and/or additional information becomes available this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

As reported: "customer stated that upon arrival and opening, there was damage to the boxes of cement and there was a strong odor.

• Brand Name: SIMPLEX P - US FULL DOSE 10-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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7493571
• MDR Text Key: 107563332
• Report Number: 0002249697-2018-01356
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 61911010
• Device Lot Number: RKY148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2017
• 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