MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; IMPLANT

Catalog Number 61910002

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

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

The distributer notied that the smell of the monomer.Probably, the ampoule of th monomer was broken.The smell was noticed in the facility of the detributor.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding packaging damage involving a simplex pack was reported.The event was confirmed.Method & results: -device evaluation and results: the outer twin carton has damage on several corners which would be an indication of excessive/incorrect handling.Both unit cartons show paper tears consistent with having become stuck together after leaking monomer would have dried up.The seal along the entire side of one of the unit cartons has completed lifted off, which is an indication of leaking monomer having dissolved the adhesive.Both ampoule blisters are deformed and the tyvek lids are at least partially opened and one of the ampoules is broken.This type of damage is consistent with leaked monomer liquid which would deform the plastic blister and dissolve the adhesive between the blister and the tyvek lid.Conclusions: based on the device evaluation, the damage to the outer twin carton would be an indication of excessive/incorrect handling, resulting in the observed damage to the unit cartons and the ampoules and their blisters.Based on the information provided by the customer, there was an odour coming from the product when the reported damage was noted.This indicates that the ampoule was broken at the time or shortly before the product was received by the customer as the smell would have come from the monomer when the ampoule was broken.This odour from the monomer liquid lasts a short period of time as the liquid evaporates when exposed to the atmosphere.Based on the device evaluation and the description of the event, it appears that this product was damaged due to inappropriate handling or storage during distribution/transportation.Ncr was raised 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.

Event Description

The distributer notied that the smell of the monomer.Probably, the ampoule of the monomer was broken.The smell was noticed in the facility of the detributor.

Manufacturer Narrative

Expiration date corrected.An event regarding packaging damage involving a simplex pack was reported.The event was not confirmed.Device evaluation not performed as no devices were returned and no photographs of the reported event were provided.Medical evaluation not performed as there was no patient involvement.Device history review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.Complaint history review determined that there were no other similar reported events for the lot.The event was not confirmed as the reported product or photographs were not provided for review.No further investigation is possible at this time.

Event Description

The distributer notied that the smell of the monomer.Probably, the ampoule of the monomer was broken.The smell was noticed in the facility of the detributor.

• Brand Name: SIMPLEX P-JAPANESE TWIN 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3888018
• MDR Text Key: 4673917
• Report Number: 0002249697-2014-02426
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 61910002
• Device Lot Number: JGU023
• Other Device ID Number: STERILE LOT 875EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2013
• 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