MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPEEDSET-US FULL DOSE 10 PK; IMPLANT

Catalog Number 61921010

Device Problems Device Damaged Prior to Use (2284); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device 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

Product delivered to hospital damaged.As per sales rep on (b)(6) 2015: the damaged packaging was noticed due to the monomer fumes.

Manufacturer Narrative

An event regarding packaging damage involving simplex packaging was reported.The event was confirmed.Method & results: device evaluation and results: one photograph was attached showing one unit carton, a deformed blister with the tyvek lid removed and an ampolue which is broken/damaged at the bottom.When the ampoule was broken the monomer leaked out causing the damage to both the tyvek seal and the blister.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: not performed as no lot provided.Complaint history review: not performed as no lot provided.Conclusions: one photograph was attached showing one unit carton, a deformed blister with the tyvek lid removed and an ampolue which is broken/damaged at the bottom.When the ampoule was broken the monomer leaked out causing the damage to both the tyvek seal and the blister.The damage appears to be consistent with inappropriate/excessive 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.If product and/or additional information becomes available this investigation will be reopened.

Event Description

Product delivered to hospital damaged.As per sales rep on 7/29/2015: the damaged packaging was noticed due to the monomer fumes.

• Brand Name: SPEEDSET-US FULL DOSE 10 PK
• 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: 5013939
• MDR Text Key: 24534919
• Report Number: 0002249697-2015-02735
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063857
• 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: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 61921010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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