MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE HFX SIZE #5; IMPLANT

Catalog Number 6077-0537

Device Problem Sticking (1597)

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

Event Date 01/09/2014

Event Type  malfunction  

Event Description

While impacting an accolade hfx stem, a custom broach handle was used and became lodged and stuck in the the stem during impaction.We opened another stem and used a thread in impactor without any further issues.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding off label use involving an accolade hfx was reported.The device was returned.The accolade hfx stem was returned for analysis.The bullet tip of the specialty offset accolade stem inserter was returned firmly stuck in the stem.It appeared the tip of the inserter was only inserted into the stem about half way.There are a few marks on the distal portion of the stem.Conclusion: it was reported that while impacting an accolade hfx stem with the specialty accolade offset stem inserter the instrument became lodged and stuck in the stem.A review of the surgical protocol for the accolade system and a review of the surgeon approval letter for the specialty accolade offset stem inserter indicated this instrument is not to be used with the accolade hfx stem; therefore, this application of the device is off label use.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

While impacting an accolade hfx stem, a custom broach handle was used and became lodged and stuck in the the stem during impaction.We opened another stem and used a thread in impactor without any further issues.

• Brand Name: ACCOLADE HFX SIZE #5
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3603412
• MDR Text Key: 4191146
• Report Number: 0002249697-2014-00249
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051741
• 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: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 6077-0537
• Device Lot Number: MLEWDK
• Other Device ID Number: STERILE LOT# MSHLH25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2012
• 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