MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE INJECTOR II NEEDLE CARTRIDGE; NEEDLE, SUTURING, DISPOSABLE

Model Number	CAT01857
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle broke during the procedure.The needle was retrieved.
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.
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: tip of the injector needle broke probable root cause: design - design stackup interference, too much clearance between catridge and loaded suture - catridge tip goemetry not sufficient for grabbing suture - cartridge design does not withstand attempted passing forces, material too weak - handle tip design does not withstand attempted passing forces, too weak - handle tip design insufficient for suture retention after passing process - handle tip not manufactured to specification - cartridge tip not manufactured to specification application - incorrect cartridge assembly - reuse of catridge - damage to cartridge during handling - difficult surrounding tissue or anatomy - improper loading of suture the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.81.
Event or Problem Description
It was reported that the needle broke during the procedure.The needle was retrieved.

• Brand Name: INJECTOR II NEEDLE CARTRIDGE
• Common Device Name: NEEDLE, SUTURING, DISPOSABLE
• 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: 15621024
• Report Number: 0002936485-2022-00596
• Device Sequence Number: 5978954
• Product Code: GAB
• UDI-Device Identifier: 07613252633105
• UDI-Public: 07613252633105
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 11/30/2022

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: CAT01857
• Device Catalogue Number: CAT01857
• Device Lot Number: 006901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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