MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5MM PROBE PACKAGING; ACCESSORIES, ARTHROSCOPIC

Catalog Number	3910-500-850
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke during the procedure.Per additional information received, all pieces were retrieved and the need for an expanded portal size does not pose additional risk to the patient as it is within the scope of the original procedural requirements to create a portal large enough to perform the surgery at the discretion of the surgeon.
Event or Problem Description
It was reported that the device broke during the procedure.Per additional information received, all pieces were retrieved and the need for an expanded portal size does not pose additional risk to the patient as it is within the scope of the original procedural requirements to create a portal large enough to perform the surgery at the discretion of the surgeon.
Additional Manufacturer Narrative
Alleged failure: alain rouffy from the hospital reported to the customer service the following event :" palpator reference 3910 500 850 850 (5mm) lot 13334, which broke intra-articularly during surgery.Actions undertaken: opening of another box." the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force applied on probe or 2) incision too small.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: 5MM PROBE PACKAGING
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8625833
• Report Number: 0002936485-2019-00212
• Device Sequence Number: 1968050
• Product Code: NBH
• UDI-Device Identifier: 04546540556103
• UDI-Public: 04546540556103
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 3910-500-850
• Device Lot Number: 13334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1