MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN EXTRACTOR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-4-804

Device Problems Degraded (1153); Sticking (1597); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

It is reported by the nurse of the hospital that after washing there is a sticky coating on the surface of the instruments.

Manufacturer Narrative

An event regarding santoprene handle degradation was reported.The event was confirmed.Method & results: device evaluation and results: visual analysis confirmed the reported event.The handle was returned degraded.Medical records received and evaluation: not performed because patient factors did not contribute to the reported event.Device history review: review of the device history records indicates all devices accepted into final stock met specifications.Complaint history review: there has been one other events for the lot referenced.Conclusions: a capa was initiated because a series of complaints were received for triathlon instrumentation where green santoprene over-mold handles have been reported to be degrading, becoming sticky and unstable.This event was determined to be under the scope of capa.Chemical and cytotoxicity tests showed the degraded santoprene is non-toxic.The ability to clean and sterilize the degraded instruments has not been compromised.

Event Description

It is reported by the nurse of the hospital that after washing there is a sticky coating on the surface of the instruments.

• Brand Name: HEADLESS PIN EXTRACTOR
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5302781
• MDR Text Key: 34352496
• Report Number: 0002249697-2015-04257
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-4-804
• Device Lot Number: MC4W01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2010
• 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