MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - US TOBRA FD 10-PK; IMPLANT

Catalog Number 61979010

Device Problems Device Emits Odor (1425); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded by the hospital and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Strong odor noticed upon delivery of bone cement indicating to customer possible broken vial(s).Customer destroyed shipment immediately and properly upon reporting to us in the local branch customer service.

Manufacturer Narrative

An event regarding packaging damage involving simplex bone cement was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no devices were returned and no photographs were provided.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.Complaint history review: review determined that there were no other similar reported events for the lot.Conclusions: based on the information provided by the customer, the smell was strong coming from the product.This indicates that an ampoule was broken at the time or shortly before the product was received by the customer.The liquid from the ampoule has a very strong odour and lasts a short period of time as the liquid evaporates when exposed to the atmosphere.Based on the information provided, it appears that this product was damaged due to inappropriate handling during distribution/transportation.A capa trend analysis was conducted for the reported failure mode and concluded simplex packaging damage may result from other factors not necessarily related to the product.No further investigation is possible at this time as no product and insufficient information was received by stryker orthopaedics.If additional information becomes available this investigation will be reopened.

Event Description

Strong odor noticed upon delivery of bone cement indicating to customer possible broken vial(s).Customer destroyed shipment immediately and properly upon reporting to us in the local branch customer service.

• Brand Name: SIMPLEX P - US TOBRA FD 10-PK
• Type of Device: IMPLANT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5084420
• MDR Text Key: 26424575
• Report Number: 0002249697-2015-03068
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014199
• 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: Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 61979010
• Device Lot Number: MDW029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• 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