MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS 4:1 IMPACTOR/EXTRACTOR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-7-806

Device Problems Degraded (1153); Residue After Decontamination (2325); Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)

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

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

I had two sets of triathlon instruments that were sterilized for two total knees.We open the first set and found the contaminated handle.We open up the second set and found another contaminated handle.Surgery was delayed and the second case had to be canceled.After separating the handle and sterilizing again for the third time, it again was contaminated with a sticky substance.

Manufacturer Narrative

An event regarding alleged "sticky handles" involving a mis 4:1 impactor/extractor was reported.The event was confirmed.Method and results: device evaluation and results: the santoprene handle coating showed signs of degradation and felt sticky.Medical records received and evaluation: not performed because it is believed 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 (b)(4) other events associated with the reported lot.Conclusions: visual inspection of the device showed the santoprene handle showed signs of degradation and felt sticky.A capa was initiated on 20-oct-2010 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 the 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

I had two sets of triathlon instruments that were sterilized for two total knees.We open the first set and found the contaminated handle.We open up the second set and found another contaminated handle.Surgery was delayed and the second case had to be canceled.After separating the handle and sterilizing again for the third time, it again was contaminated with a sticky substance.

• Brand Name: MIS 4:1 IMPACTOR/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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5505019
• MDR Text Key: 40501075
• Report Number: 0002249697-2016-00848
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

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: 6541-7-806
• Device Lot Number: C2H01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2007
• 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