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

Catalog Number 1020-1400

Device Problems Break (1069); Detachment Of Device Component (1104); 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 04/03/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

The surgeon was using the exeter broach handle in a total hip replacement when it broke.The wheel snapped off.

Manufacturer Narrative

An event regarding cracking/fracture involving an accolade handle was reported.The event was confirmed.Method & results: device evaluation and results: examination with material analysis engineer confirmed the impaction pad broke from the rasp handle body at the weld location.The fracture surface was confirmed to be consistent with similar events reported for this product and under the scope of ncr m08-1901, therefore further evaluation is not required.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.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 events for this lot.Conclusions: the event was confirmed.A review of stryker¿s nc/capa database indicated that ncr (b)(4) resulted in regulatory action ra2009-050 (approved nov.1, 2010) which recalled the device for the potential fracturing/breakage of the straight rasp handle.All lots were recalled.The device reported in this event was manufactured before this recall.

Event Description

The surgeon was using the exeter broach handle in a total hip replacement when it broke.The wheel snapped off.

• Brand Name: ACCOLADE OFFSET RASP HANDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5623908
• MDR Text Key: 44192500
• Report Number: 0002249697-2016-01463
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• 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: PYT55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2249697-11/11/10-007-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other