MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; IMPLANT

Catalog Number 6197-9-001

Device Problems Break (1069); Out-Of-Box Failure (2311); Chemical Spillage (2894)

Patient Problem No Information (3190)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

It was reported that the sales rep opened the simplex packaging get ready for a case.The vial was broken and the liquid had dried in the package.Patient was in the or but not affected as back up dosage was immediately available.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.(b)(4).

Manufacturer Narrative

An event regarding packaging damage involving a simplex packaging was reported.The event was not confirmed.Review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.Review determined that there were no other similar reported events for the lot.Other than that the simplex unit carton was received damaged at the hospital in that the vial was broken and the liquid had dried up, no further information was provided.Based on this, the exact cause of the event could not be determined, but it appears that this product was damaged due to inappropriate handling or storage during distribution/transportation.Ncr (b)(4) was raised in (b)(6) 2010 to address a trend noted for damage to simplex packaging.This trend was based on the volume of complaints received associated with packaging damage for simplex product.Upon application of adverse trend detection it was determined that the rate is within the risk acceptability criteria.Package design review was carried out as part of the ncr and it was determined that further design review will be completed under packaging innovation quality improvement projects.No further investigation is possible at this time as no product and insufficient information was received by stryker orthopaedics.

Event Description

It was reported that the sales rep opened the simplex packaging get ready for a case.The vial was broken and the liquid had dried in the package.Patient was in the or but not affected as back up dosage was immediately available.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3659135
• MDR Text Key: 14882142
• Report Number: 0002249697-2014-00623
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MHT079
• Other Device ID Number: STERILE LOT 120564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2012
• 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
• Patient Age: 69 YR