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

Catalog Number 2124-1750

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During implanting the accolade ii, the accolade double offset was broken and couldn't connect the broach.It was replaced by another broach handle.It was confirmed the broken part of the broach handle before closure wound, removed the broken part out of patient's body and the procedure was completed.

Manufacturer Narrative

An event regarding crack/fracture of lever involving a dual-offset accolade rasp handle was reported.The event was confirmed.Method & results: device evaluation and results:the device was returned in used condition.The left lever sub-assembly was returned fracture along with fractured part which confirming the event.There are many scratches and dents around the device.Examination of the returned device with material analysis engineer indicated the fracture is consistent with overload condition.Medical records received and evaluation: not performed as there were no medical records.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: visual inspection confirms the left lever sub-assembly fractured.Material analysis engineer indicated that the fracture is consistent with overload condition.If additional information and/or device become available, this investigation will be reopened.

Event Description

During implanting the accolade ii, the accolade double offset was broken and couldn't connect the broach.It was replaced by another broach handle.It was confirmed the broken part of the broach handle before closure wound, removed the broken part out of patient's body and the procedure was completed.

• Brand Name: LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6384555
• MDR Text Key: 69520026
• Report Number: 0002249697-2017-00812
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• 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: 05/24/2017

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: 2124-1750
• Device Lot Number: P8V33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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