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

Catalog Number 1440-2011

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 04/14/2015

Event Type  malfunction  

Event Description

It was reported that when the surgeon was putting in the cup with the da magnetic cup impactor, he went to removed the magnetic impactor and it cold welded to the cup.The surgeon was unable to remove the cup, so another cup was opened.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding difficulty disassembling a da impactor bolt from a shell was reported.The event was confirmed.Method & results: -device evaluation and results: a function analysis confirmed the reported disassembly difficulty.Inspection of the device found no damage to the product.In addition, no manufacturing non-conformances were identified.-medical records received and evaluation: not performed as patient factors did not contribute to the reported event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no previous reported events for this lot id.Conclusions: it was determined that no manufacturing non-conformities were identified.However, this device is in scope of a non-conformance report to further investigate the root cause of similar reported events.

Event Description

It was reported that when the surgeon was putting in the cup with the da magnetic cup impactor, he went to removed the magnetic impactor and it cold welded to the cup.The surgeon was unable to remove the cup so another cup was opened.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4765162
• MDR Text Key: 5784270
• Report Number: 0002249697-2015-01494
• 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: 04/14/2015

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: 1440-2011
• Device Lot Number: DC236750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2013
• 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