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

Catalog Number 61911010

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Approx 2 boxes of cement were delivered to hospital receiving department leaking.Receiving accepted the shipment.We picked up the leaking cement on (b)(6) 2016 when we were notified and we replaced the two boxes with two of our stock.

Manufacturer Narrative

An event regarding packaging damage involving simplex bone cement was reported.The event was confirmed.Photographs of shipper boxes and 10 pack boxes were provided.Both corrugated boxes and 10 pack boxes were significantly damaged with the sides and corners of the boxes compressed and torn.The shipper boxes would each contain two 10-packs of bone cement.Photographs of the single packs within the 10-packs were not 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.Based on the provided photographs, 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

Two boxes of cement were delivered to hospital receiving department leaking.Receiving accepted the shipment.We picked up the leaking cement on (b)(6) 2016 when we were notified and we replaced the two boxes with two of our stock.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5823303
• MDR Text Key: 51227244
• Report Number: 0002249697-2016-02447
• 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: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 61911010
• Device Lot Number: RDX043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• 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