MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ANATO FEMORAL BROACH SZ1 LEFT; HIP INSTRUMENT

Catalog Number 4845-2-961

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a hip case, surgeon used the anato broaches and found that the trial part after broaching had a tight fit but when surgeon attempted implantation of actual stem the stem countersunk in hip.

Manufacturer Narrative

An event regarding size/fit involving an anato rasp was reported.The event was not confirmed.Method & results: device evaluation and results: slight staining was noted around the broach.The returned device was otherwise unremarkable.Dimensional inspection determined the device to be within specification.Medical records received and evaluation: there were insufficient medical records were received for review with a clinical consultant 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 other similar events for the reported lot.Conclusions: the event could not be confirmed based on the information available.The returned stem was inspected by the supplier and was confirmed to be within dimensional specification.No further investigation is required at this time.If additional relevant information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that during a hip case, surgeon used the anato broaches and found that the trial part after broaching had a tight fit but when surgeon attempted implantation of actual stem the stem countersunk in hip.

• Brand Name: ANATO FEMORAL BROACH SZ1 LEFT
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5302540
• MDR Text Key: 34331171
• Report Number: 0002249697-2015-04252
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 4845-2-961
• Device Lot Number: 79230017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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