MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE COBRA SUTURE PASSER, CAPTURE; ACCESSORIES, ARTHROSCOPIC

Catalog Number 3910-900-093

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2023

Event Type  malfunction  

Event Description

Per investigation results, the needle was bent resulting in that the needle became bent while the device was in use.

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.

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: needle/suture cannot be passed through.Probable root cause: design: inadequate raw material selection.Tip geometry not designed to facilitate soft tissue penetration.Needle not designed to withstand multiple usages/reprocessing cycles process.Instrument not manufactured / serviced to specification application.Attempt to use the device with broken or bent needle.Attempt to pass through thick tissue or bone.Excessive tissue loaded into jaws.Lack of due care when inserting instrument into soft tissue.Use of excessive force.Attempt to load or pass incompatible suture.Technique error.Improper reprocessing cycles/agents used; reprocessing instructions not followed.The reported failure mode will be monitored for future reoccurrence.*note: the investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: the instruments had a problem with the needle when passing the suture thread.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) attempt to use the device with bent needle, 2) use of excessive force, 3) attempt to pass through thick tissue or bone, 4) excessive tissue loaded into jaws, 5) attempt to load or pass incompatible suture, 6) technique error.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

Per investigation results, the needle was bent resulting in that the needle became bent while the device was in use.

• Brand Name: COBRA SUTURE PASSER, CAPTURE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 17409818
• MDR Text Key: 319924233
• Report Number: 0002936485-2023-00729
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 3910-900-093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male