MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PORTAL ENTRY KIT; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	CAT00241
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that product broke during use.All broken pieces were retrieved.
Event or Problem Description
It was reported that product broke during use.All broken pieces were retrieved.
Additional Manufacturer Narrative
A hip arthroscopy procedure was being carried out.The surgeon was using a flexible guide wire from a portal entry kit.The guide wire snapped into 2 pieces inside the hip joint.The surgeon had to remove the both pieces.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: excessive force applied on device or improper insertion.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• Brand Name: PORTAL ENTRY KIT
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7629841
• Report Number: 0002936485-2018-00500
• Device Sequence Number: 16612327
• Product Code: KDD
• UDI-Device Identifier: 07613252632863
• UDI-Public: 07613252632863
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: CAT00241
• Device Lot Number: LOT003116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1