MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II BROACH; INSTRUMENT

Catalog Number 1020-5204

Device Problems Device Inoperable (1663); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/15/2014

Event Type  malfunction  

Event Description

It was reported patient had a primary total hip replacement, doctor was unable to attain fixation with appropriate size broach therefore, he was unable to implant stryker accolade ii hip.This led to a delay in surgery of 10 minutes.Update from sales rep (b)(6) 2014: during procedure, several different broaches were used and all of them had an issue.The surgeon and sales rep were concerned that all of the broaches in the instrument set were defective and will return them all.

Manufacturer Narrative

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

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual inspection: the devices showed signs of normal wear/use.Dimensional inspection: not performed as the device was returned in a worn/used condition and therefore will not meet dimensional specifications.In addition, discussions with the sales rep disclosed that dr.Considers this event to be a non issue at this point as he is now satisfied with the fit of the accolade broaches.As stated in the complaint history review, trend request has been submitted for a surgeon commonality for accolade ii broaches relative to stem seating/locking issues with dr.Functional inspection: not performed because the event occurred in vivo and therefore functionality could not be duplicated.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported patient had a primary total hip replacement, doctor was unable to attain fixation with appropriate size broach therefore, he was unable to implant stryker accolade ii hip.This led to a delay in surgery of 10 minutes.Update from sales rep 08/06/2014: during procedure, several different broaches were used and all of them had an issue.The surgeon and sales rep were concerned that all of the broaches in the instrument set were defective and will return them all.

• Brand Name: SIZE 4 ACCOLADE II BROACH
• Type of Device: INSTRUMENT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4048240
• MDR Text Key: 15122846
• Report Number: 0002249697-2014-03308
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2014

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 Catalogue Number: 1020-5204
• Device Lot Number: B7WAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/06/2014
• Initial Date FDA Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR