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

Catalog Number 6541-4-300

Device Problems Degraded (1153); Material Discolored (1170); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Product handles were reported to be discoloured and degrading.

Manufacturer Narrative

Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock between 28-sep-2009 and 01-oct-2009 with no reported discrepancies.Based on the device identification the complaint databases were reviewed from 2009 to present for similar reported events regarding santoprene damage.Lot id: there has been one other event for the lot referenced.Trend detection: a review of the trending project folder indicates that there is no existing trend analysis for this product and issue.Visual inspection: the device was returned in used condition.Visual inspection confirmed that the green santoprene handle was discolored and degraded.One of the green santoprene handles were also missing.Conclusion: the event was confirmed; the device handle is discolored and damaged.The sales representative indicated that the hospital has been experiencing some sterilization issues and using a metal cleaning chemical which could have been a contributing factor to the damage found.The damaged device was discovered during inspection; there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Product handles were reported to be discoloured and degrading.

• Brand Name: HEADED PIN 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5563640
• MDR Text Key: 42198201
• Report Number: 0002249697-2016-01168
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-4-300
• Device Lot Number: MC4H12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2009
• 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