MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SLINGSHOT 70 DEG UP; PASSER

Model Number	CAT02590
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
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 inner sheath broke off into the patient during the procedure.The piece was retrieved.
Additional Manufacturer Narrative
Alleged failure: the surgeon was pulling the slingshot out of the patient with suture sucked into the device and the inner metal sheath separated from the outer sheath and remained in the joint.The surgeon was able to remove the piece from the patient without incident or damage to the patient.There were no adverse effects on the surgery.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force applied on device, 2) difficult anatomy, extremely tough soft tissue, or 3) manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the inner sheath broke off into the patient during the procedure.The piece was retrieved.

• Brand Name: SLINGSHOT 70 DEG UP
• Common Device Name: PASSER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10653191
• Report Number: 0002936485-2020-00407
• Device Sequence Number: 2961902
• Product Code: HWQ
• UDI-Device Identifier: 07613252656616
• UDI-Public: 07613252656616
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/19/2020

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: CAT02590
• Device Catalogue Number: CAT02590
• Device Lot Number: 005122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1