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); Material Integrity Problem (2978)

Patient Problem 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

Noticed that triathlon mis 4:1impactor/extractor was leaving a blue residue on other insts.

Manufacturer Narrative

An event regarding alleged "blue residues" involving a mis 4:1 impactor/extractor was reported.The event was not confirmed.Method & results: device evaluation and results: the santoprene handle coating was degraded.However, the blue residue was not apparent.Device history review indicated all devices accepted into stock met specification.Complaint history review indicated there have been no other events associate with the reported lot.Conclusions: visual inspection of the device showed the santoprene handle coating was degraded.However, the blue residue was not apparent.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

Noticed that triathlon mis 4:1 impactor/extractor was leaving a blue residue on other insts.

• 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: 5454719
• MDR Text Key: 38821818
• Report Number: 0002249697-2016-00434
• 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: 01/19/2016

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: 6541-7-806
• Device Lot Number: SB4L25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2010
• 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