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

Catalog Number 1440-2011

Device Problems Mechanical Problem (1384); Sticking (1597); Fitting Problem (2183); Mechanical Jam (2983)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

During a primary hip surgery, surgeon was using the curved impactor to seat the cup.During the process the bolt got stuck in the cup and as a result the cup had to be removed as cup was well fixed but due to bolt sticking in cup, a new cup had to be implanted.Approximately a 10 minute delay in surgery as a result as a new cup had to be opened and the surgical site re-reamed.Correction per sales rep: surgical site did not have to be re-reamed.Only took out first cup and put in new cup.

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 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

During a primary hip surgery, surgeon was using the curved impactor to seat the cup.During the process the bolt got stuck in the cup and as a result the cup had to be removed as cup was well fixed but due to bolt sticking in cup, a new cup had to be implanted.Approximately a 10 minute delay in surgery as a result as a new cup had to be opened and the surgical site re-reamed.Correction per sales rep: surgical site did not have to be re-reamed.Only took out first cup and put in new cup.

• 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: 4888296
• MDR Text Key: 6069947
• Report Number: 0002249697-2015-02185
• 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: 06/08/2015

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: DC232519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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