MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HIP 4.0MM CANNULA; ACCESSORIES, ARTHROSCOPIC

Catalog Number	0295723100
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
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.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: we found x3 kits without tray lists and x1 without a decon.The probe ((b)(6)) was bent and got stuck inside the patient, after a while the surgeon managed to remove it.We did try to straighten it afterwards, however, it'd still crooked.The surgeon placed a cannula ((b)(6)) inside the patient and it broke.Please see photo attached.This again took time to remove from the patient.The suture cutter ((b)(6)) has somehow broken also, so please could that be looked at.Update (b)(6)2023 a consumable cannula instead to successfully complete procedure.Please estimate any surgical delay, even if under a minute (or indicate ¿none¿ to confirm there was absolutely no delay) yes, approx.3 minutes ¿ surgeon name (first and last): tim board ¿ case type ¿ hip arthroscopy.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: HIP 4.0MM CANNULA
• Common Device Name: 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17785290
• Report Number: 0002936485-2023-00952
• Device Sequence Number: 5492683
• Product Code: NBH
• UDI-Device Identifier: 07613327052886
• UDI-Public: 07613327052886
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/07/2024

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: 0295723100
• Device Lot Number: 230004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown