MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH IMPACTION HANDLE; INSTRUMENT

Catalog Number 6541-4-810

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

The handle melted after sterilization.Spare product was shipped to the hospital before the medical procedure.

Manufacturer Narrative

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

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 indicated all devices accepted into stock met specification.-complaint history review indicated there have been other events associate with the reported lot.Conclusions: 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 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

The handle melted after sterilization.Spare product was shipped to the hospital before the medical procedure.

• Brand Name: IMPACTION HANDLE
• Type of Device: INSTRUMENT
• 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: 4814838
• MDR Text Key: 17696130
• Report Number: 0002249697-2015-01792
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• 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: N3E30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2008
• 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