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

Catalog Number 6541-4-810

Device Problems Degraded (1153); Residue After Decontamination (2325); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

I was called into the room during a tka wile they were opening trays.There was a grease color brown consisting of oil on the instruments with green handles.

Manufacturer Narrative

An event regarding alleged santoprene handle degradation involving a triathlon impaction handle was reported.The event was not confirmed.Method & results: device evaluation and results: the device was returned in used condition.Visual inspection indicated that, while the santoprene coating was worn and off color, the device was otherwise clean and appeared in serviceable condition.Oil and/or grease residue was not apparent.Medical records received and evaluation: not performed because patient factors did not contribute to the reported event.Device history review: indicated all devices accepted into stock met specification.Complaint history review: indicated there have been other events associated with the reported lot.Conclusions: conversation with the sales representative indicated oil and/or grease residue was discovered shortly after routine cleaning at the hospital.Visual inspection at stryker orthopaedics indicated that, while the santoprene coating was worn and off color, the device was otherwise clean and appeared in serviceable condition.Oil and/or grease residue was not apparent.

Event Description

I was called into the room during a tka wile they were opening trays.There was a grease color brown consisting of oil on the instruments with green handles.

• Brand Name: IMPACTION HANDLE
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5454739
• MDR Text Key: 38821317
• Report Number: 0002249697-2016-00428
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-4-810
• Device Lot Number: CR1N01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2008
• 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