MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 2.7MM MICRO SCISSOR PUNCH; ACCESSORIES, ARTHROSCOPIC

Catalog Number 0300027603

Device Problems Break (1069); Sticking (1597)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/23/2014

Event Type  Injury  

Event Description

It was reported that the device was stuck in the patient due to the top jaw breaking.

Manufacturer Narrative

The product was returned and the failure mode was confirmed.The top jaw of the micro scissor punch has broken off.Unable to function test the punch due to the broken jaw.The probable root cause could be user excessive force.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the device was stuck in the patient due to the top jaw breaking.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

• Brand Name: 2.7MM MICRO SCISSOR 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: 3818767
• MDR Text Key: 4742830
• Report Number: 0002936485-2014-00347
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0300027603
• Device Lot Number: 4428A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2014
• 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