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

Model Number	CAT02862
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2019
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.The piece was retrieved.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: a 70a slingshot above is used for a bankar arthroscopic procedure, the glena is perforated, the arms of the clamp are expanded, the suture is recovered and one of the arms is split.The failure identified in the investigation is consistent with the complaint record.The probable root causes could be: excessive force applied on device, user technique related factors, or difficult anatomy, extremely tough soft tissue.The device manufacture date is not known.
Event or Problem Description
It was reported that the device broke.The piece was retrieved.

• Brand Name: CHAMPION SLINGSHOT 70 UP
• Common Device Name: PASSER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9564719
• Report Number: 0002936485-2020-00014
• Device Sequence Number: 11368223
• Product Code: HWQ
• UDI-Device Identifier: 07613327123715
• UDI-Public: 07613327123715
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: CAT02862
• Device Catalogue Number: CAT02862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1