MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CURVED CUP IMPACTOR; IMPLANT

Catalog Number 1440-2010

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2015

Event Type  malfunction  

Event Description

It was reported that direct anterior curved cup impact or broke at the end of handle.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding a fractured da instrument impaction handle was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis found no material or manufacturing defects.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: all devices accepted into final goods conformed to specification.-complaint history review: there have been similar previous reported events for this lot id.Conclusions: the investigation concluded that the device fractured in fatigue.No material or manufacturing defects were identified.

Event Description

It was reported that direct anterior curved cup impact or broke at the end of handle.

• Brand Name: CURVED CUP IMPACTOR
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4562710
• MDR Text Key: 5549710
• Report Number: 0002249697-2015-00539
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1440-2010
• Device Lot Number: DC239163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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