MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HIP 5.5MM CANNULA; ACCESSORIES, ARTHROSCOPIC

Catalog Number	UNK_END
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2019
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 device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: the customer reported that during a hip arthroscopy procedure, the cannula snapped inside the patient.A pair of grips were used to remove the unintended metal piece successfully.There was a short delay to the procedure (less than 30 minutes) and no other detriment to the patient the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be 1) user excessive force 2) normal wear and tear the product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.Gtin: (b)(4).
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.

• Brand Name: HIP 5.5MM CANNULA
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9220596
• Report Number: 0002936485-2019-00476
• Device Sequence Number: 19552559
• Product Code: NBH
• UDI-Device Identifier: 07613327052992
• UDI-Public: 07613327052992
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: UNK_END
• Device Lot Number: 172956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1