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

Catalog Number 61979010

Device Problems Contamination (1120); Device Emits Odor (1425); Out-Of-Box Failure (2311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

Upon receipt of shipment customer stated that there was an overwhelming smell emanating from the box.They were aware that one of the vials was probably broken and called the branch office.Both cases of cement were contaminated and destroyed at facility.The outer shipping carton did indicate damage.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding packaging damage involving simplex packaging was reported.The event was confirmed.Method and results: photographs of the shipper box were provided.The corrugated shipper box has evidence of severe damage; there are compression dents on two corners and the box has been perforated and torn.Photographs of the 10-packs that were shipped in this box were not provided.Review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.Review of the complaint history determined that there were no other similar reported events for the lot.Conclusions: based on the photographs provided, the corrugated shipper box has evidence of severe damage; there are compression dents on two corners and the box has been perforated and torn.Photographs of the 10-packs that were shipped in this box were not provided.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.

Event Description

Upon receipt of shipment customer stated that there was an overwhelming smell emanating from the box.They were aware that one of the vials was probably broken and called the branch office.Both cases of cement were contaminated and destroyed at facility.The outer shipping carton did indicate damage.

• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4777358
• MDR Text Key: 5802290
• Report Number: 0002249697-2015-01583
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 61979010
• Device Lot Number: MAW009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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