MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROX FEM COM TROCHANTERIC; IMPLANT

Catalog Number 64951002

Device Problems Device Damaged Prior to Use (2284); Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient 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.

Event Description

It was reported that during a left primary proximal femoral procedure, when the nurse went to open the outer blister on the device before passing to the sterile field, the outer blister came off quickly and stuck to the blister was a piece of the plastic from the outer packaging and the packaging fell onto the table in the sterile field as a result causing the area and table to be quarantined and a new table had to be prepped and new trays opened to complete the case causing approximately a 10 minute delay in the surgery proceeding.The inner component packaging was well sealed and the inner packaging was opened and the component was implanted and the case completed.

Manufacturer Narrative

An event regarding packaging damage involving a gmrs femoral component was reported.The event was confirmed.Method & results: device evaluation and results: no product or packaging were returned for evaluation.One photograph was attached.The photograph shows the tyvek lid from the outer blister and a piece of plastic.The plastic appears to be the flange of the outer blister.This type of damage would be consistent with a shock load,e.G.The carton being dropped from a height and/or compression.Medical records received and evaluation: not performed as the event relates to a packaging issue device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no similar events for the reported lot.Conclusions: the investigation concluded that the most likely cause of the packaging damage was consistent with a shock load,e.G.The carton being dropped from a height and/or compression.No further investigation for this event is possible at this time.

Event Description

It was reported that during a left primary proximal femoral procedure, when the nurse went to open the outer blister on the device before passing to the sterile field, the outer blister came off quickly and stuck to the blister was a piece of the plastic from the outer packaging and the packaging fell onto the table in the sterile field as a result causing the area and table to be quarantined and a new table had to be prepped and new trays opened to complete the case causing approximately a 10 minute delay in the surgery proceeding.The inner component packaging was well sealed and the inner packaging was opened and the component was implanted and the case completed.

• Brand Name: GMRS PROX FEM COM TROCHANTERIC
• 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: 5063186
• MDR Text Key: 25828257
• Report Number: 0002249697-2015-02939
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 64951002
• Device Lot Number: EDX8T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2013
• 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
• Patient Age: 51 YR