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

Catalog Number 61979010

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device 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.

Event Description

The box came in this morning, (b)(6) and the receiving clerks noticed a strong odor when they went to receive it.When they opened the brown box and took the white box out they noticed an area that had leaked which was causing the strong odor.

Manufacturer Narrative

An event regarding packaging damage involving simplex bone cement was reported.The event was confirmed.Method & results: -device evaluation and results: the product was not returned for evaluation however photographs of the shipper box and damaged 10-pack carton were provided.There are moisture marks visible on the shipper box and the sides appear to have been compressed.The top of the 10-pack carton is dented and there is a tear visible on the bottom of the 10-pack.-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: the product was not returned for evaluation however photographs of the shipper box and damaged 10-pack carton were provided.There are moisture marks visible on the shipper box and the sides appear to have been compressed.The top of the 10-pack carton is dented and there is a tear visible on the bottom of the 10-pack.It was reported that the customer noted an odor coming from the pack of bone cement upon receipt at the hospital.The odor indicates that the monomer leakage from the ampoule was recent, as monomer evaporates into the atmosphere over time.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

The box came in this morning (b)(6) and the receiving clerks noticed a strong odor when they went to receive it.When they opened the brown box and took the white box out they noticed a area that had leaked which was causing the strong odor.

• Brand Name: SIMPLEX P - US TOBRA FD 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5944039
• MDR Text Key: 54822131
• Report Number: 0002249697-2016-02903
• 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: Initial,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 61979010
• Device Lot Number: MDX032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2016
• 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