MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CANNULA 6.5MM 2 ROT STCKS (SPEED-LOCK); ACCESSORIES, ARTHROSCOPIC

Model Number	0377031650
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2020
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 the o-ring broke off the cannula and went missing during procedure.Note that an x-ray was called due to the missing o-ring and no missing object was found inside the patient.The procedure was completed successfully.
Event or Problem Description
It was reported that the o-ring broke off the cannula and went missing during procedure.Note that an x-ray was called due to the missing o-ring and no missing object was found inside the patient.The procedure was completed successfully.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: o-ring broke.Probable root cause: poor autoclave reliability, use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG, CANNULA 6.5MM 2 ROT STCKS (SPEED-LOCK)
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10402092
• Report Number: 0002936485-2020-00340
• Device Sequence Number: 3105315
• Product Code: NBH
• UDI-Device Identifier: 07613327057782
• UDI-Public: 07613327057782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/10/2020

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 Model Number: 0377031650
• Device Catalogue Number: 0377031650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1