MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT; INSTRUMENT

Catalog Number 1440-2011

Device Problems Mechanical Problem (1384); Separation Failure (2547); Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/29/2014

Event Type  malfunction  

Event Description

It was reported that item 1440-2019 and item 1440-2011 wedged together and will not separate.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding difficulty disassembling the cup impactor bolt from a da cup impactor handle was reported.The event was confirmed.Method & results: -device evaluation and results: no material or manufacturing defects were observed on the returned device.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review found no other similar events have been reported for the subject manufacturing lot.Conclusions: damage to the returned cup impactor handle indicated the handle was rotationally misaligned with the bolt during impaction.The misalignment resulted in deformation of the impactor handle mating feature which caused the reported disassembly difficulty.Material analysis found no evidence of material or manufacturing defects on the returned impactor handle.

Event Description

It was reported that item 1440-2019 and item 1440-2011 wedged together and will not separate.

• Brand Name: CUP IMPACTOR BOLT
• Type of Device: 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4441693
• MDR Text Key: 5394868
• Report Number: 0002249697-2015-00156
• 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: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1440-2011
• Device Lot Number: DC241827
• 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
• Date Device Manufactured: 07/31/2014
• 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