MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE OFFSET RASP HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1020-1400

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

The agent reported that the accolade offset rasp.Handle pulled out of the handle when it is tough to remove it.It has been attached again and it works.The device detached from the broom while the surgeon was knocking it to remove the broach.

Manufacturer Narrative

An event regarding disassembly issue involving an accolade handle was reported.The event was not confirmed.A visual inspection confirmed that the device was returned in visibly used condition but no notable damage was observed.A functional inspection confirmed the rasp was successfully mounted and removed with normal hand pressure.The accolade handle was confirmed to be fully functional.Medical records received and evaluation: not performed because no patient clinical information was provided.The reported device was manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events reported for this manufacturing lot.The reported event was not confirmed based on a functional test conducted.Based on the functional test device performed as intended.It was also concluded that there is no indication the event is related to a manufacturing issue.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

The agent reported that the accolade offset rasp.Handle pulled out of the handle when it is tough to remove it.It has been attached again and it works.The device detached from the broom while the surgeon was knocking it to remove the broach.

• Brand Name: ACCOLADE OFFSET RASP HANDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6983192
• MDR Text Key: 90969015
• Report Number: 0002249697-2017-03121
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

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: 1020-1400
• Device Lot Number: P3W15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2009
• 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