MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE NANOPASS REACH CRESCENT; PASSER

Catalog Number	CAT02298
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device jaw broke during the procedure.The piece was retrieved.
Additional Manufacturer Narrative
Alleged failure: piece of jaw from the nanopass broke off during labral repair.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) user technique related factors, 2) difficult anatomy, extremely tough soft tissue, 3) use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that the device jaw broke during the procedure.The piece was retrieved.
Additional Manufacturer Narrative
The device manufacturer date is not known.Alleged failure: piece of jaw from the nanopass broke off during labral repair.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: user technique related factors, difficult anatomy, extremely tough soft tissue, use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: NANOPASS REACH CRESCENT
• Common Device Name: PASSER
• 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: 18460682
• Report Number: 0002936485-2024-00017
• Device Sequence Number: 7079529
• Product Code: HWQ
• UDI-Device Identifier: 07613252633204
• UDI-Public: 07613252633204
• 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): 07/15/2024

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: CAT02298
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown