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

Catalog Number 61911010

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Hospital received box of cement from (b)(6) (1 10-pack in single packaged box).They said the outside of box looked fine but was re-taped.When they opened the box, case of cement was inside plastic bag like the package had been damaged by (b)(6), put in a plastic bag and re-boxed.They could smell that the vials were broken.They did not open the case to see how many vials were broken or how they had been broken.They disposed of all 10 doses of cement.No (b)(6) report linked to this as they did not show package was damaged from the outside.

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: indicate all devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: review determined that there were no other similar reported events for the lot.Conclusion: based on the information provided by the customer, the box was re-taped.When they opened the box, case of cement was inside a plastic bag like the package had been damaged by fed ex, put in a plastic bag and re-boxed.They could smell that the vials were broken.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.However, without the return and inspection of the device, the event can not be confirmed.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

Hospital received box of cement from (b)(6) (1 10-pack in single packaged box).They said the outside of box looked fine but was re-taped.When they opened the box, case of cement was inside plastic bag like the package had been damaged by (b)(6), put in a plastic bag and re-boxed.They could smell that the vials were broken.They did not open the case to see how many vials were broken or how they had been broken.They disposed of all 10 doses of cement.No (b)(6) report linked to this as they did not show package was damaged from the outside.

• 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 NJ NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6186236
• MDR Text Key: 63144798
• Report Number: 0002249697-2016-03950
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 61911010
• Device Lot Number: RJX124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• 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