MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 1-3 KEEL PUNCH GUIDE; INSTRUMENT

Catalog Number 6541-2-713

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

Staff made rep aware that devices "potentially" had adhesive melt under rubber handle.Noticed oil in bottom of tray when it came out of autoclave.No patient outcome was compromised because pan wasn't in o.R.Room and additional trays were available and used.

Manufacturer Narrative

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

Manufacturer Narrative

Visual inspection confirmed the reported event; the handle of the device is discolored and degraded.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

Staff made rep aware that devices "potentially" had adhesive melt under rubber handle.Noticed oil in bottom of tray when it came out of autoclave.No patient outcome was compromised because pan wasn't in o.R.Room and additional trays were available and used.

• Brand Name: SIZE 1-3 KEEL PUNCH GUIDE
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4527061
• MDR Text Key: 5412510
• Report Number: 0002249697-2015-00382
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-713
• Device Lot Number: N3K11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2008
• 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