MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 3.4MM 30° LEFT BIG BITE PUNCH; ACCESSORIES, ARTHROSCOPIC

Catalog Number 0300034102

Device Problems Corroded (1131); Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

It was reported that the handpiece was sterilized before going to the surgery.However, corrosion was determined when the sterile set was opened during the surgery.No adverse consequences were reported.

Event Description

It was reported that the handpiece was sterilized before going to the surgery.However, corrosion was determined when the sterile set was opened during the surgery.No adverse consequences were reported.

Manufacturer Narrative

The reported device was not received for investigation; therefore, the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: improper storage conditions, improper handling, sterilization process not effective, improper cleaning process, surface irregularities prevent complete sterilization/tissue removal.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.The product was not returned for investigation, therefore the reported failure mode could not be confirmed.The failure mode will be monitored for future reoccurrence.            .

Manufacturer Narrative

The product was returned and the failure mode was confirmed.The punch was visually inspected for damages, and corrosion was noticed on the teeth of the jaw.Corrosion was also noticed on the lot and part number on the handle.The punch was tested with porvair, and was able to cut without issues.The probable root causes could be improper storage condition or improper drying after cleaning/sterilization.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

• Brand Name: 3.4MM 30° LEFT BIG BITE PUNCH
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4587990
• MDR Text Key: 5481558
• Report Number: 0002936485-2015-00129
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2015

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: 0300034102
• Device Lot Number: K1011JT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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