MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE BIG DOG SUTURE CUTTER; CUTTER, WIRE

Model Number	0234102102
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2022
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 during the procedure.All pieces were retrieved.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.
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: instrument broken probable root cause: design: poor mechanical advantage design inadequate material selection for cutter (distal or proximal features) distal assembly of cutter susceptible to fragmentation break away pin too weak excessive interference between jaw and shaft (big dog only) process: inadequate assembly of cutter cutting edge inadvertently dulled during manufacturing use error the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: BIG DOG SUTURE CUTTER
• Common Device Name: CUTTER, WIRE
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13827294
• Report Number: 0002936485-2022-00128
• Device Sequence Number: 5083552
• Product Code: HXZ
• UDI-Device Identifier: 07613327173451
• UDI-Public: 07613327173451
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/03/2022

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: 0234102102
• Device Catalogue Number: 0234102102
• Device Lot Number: 62336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2022
• Supplement Date Received by Manufacturer: 02/19/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown