MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II BROACH; INSTRUMENT

Catalog Number 1020-5205

Device Problem Device Inoperable (1663)

Patient Problem 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.

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.This event has been identified as a duplicate.It was reported under mfr report #0002249697-2014-03311.Investigation conclusion will be documented on the referenced report.

Manufacturer Narrative

This event has been identified as a duplicate.It was reported under mfr report #0002249697-2014-03311.Investigation conclusion will be documented on the referenced report.

• Brand Name: SIZE 5 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4048178
• MDR Text Key: 15178994
• Report Number: 0002249697-2014-03303
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 1020-5205
• Device Lot Number: B8HAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 08/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2013
• 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