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

Model Number	CAT02590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
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 a piece of the device was left in the joint.
Event or Problem Description
It was reported that a piece of the device was left in the joint.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: lower jaw of the slingshot broke off.Probable root cause: design: - inadequate raw material selection.- tip geometry not designed to facilitate soft tissue penetration.Manufacturing: - instrument tip or needle shaft not manufactured to specification.- incorrect raw materials used for manufacture.Application: - user technique related factors.- difficult anatomy, extremely tough soft tissue.The reported failure mode will be monitored for future re-occurrence.

• 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: 9687519
• Report Number: 0002936485-2020-00056
• Device Sequence Number: 16979660
• Product Code: HWQ
• UDI-Device Identifier: 07613252656616
• UDI-Public: 07613252656616
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CAT02590
• Device Catalogue Number: CAT02590
• Device Lot Number: 004085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other