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

Model Number 3910900093

Device Problems Break (1069); Component Missing (2306)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

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 Description

It was reported that the needle broke during the procedure.All pieces were retrieved.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: stopped working.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 (g10).Lack of due care when inserting instrument into soft tissue (g4).Use of excessive force (g5).Attempt to load or pass incompatible suture (g6).Technique error (g7).Improper reprocessing cycles/agents used; reprocessing instructions not followed (r1).The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that the needle broke during the procedure.All pieces were retrieved.

• 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: 15933575
• MDR Text Key: 305280640
• Report Number: 0002936485-2022-00727
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327413595
• UDI-Public: 07613327413595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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 Model Number: 3910900093
• Device Catalogue Number: 3910-900-093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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