MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIR MENISCUS SYSTEM, CURVED; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number 4720

Device Problems Mechanical Problem (1384); Migration (4003)

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

Event Date 07/30/2021

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 found that a small piece of the anchor had broken off and it potentially remains in the patient.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: implants popped out during tightening of suture.Probable root cause: alleged failure: implants of the air were popped out form the meniscus during tightening the suture.The probable root cause could be use of excessive force.The device manufacture date is not known.The failure mode will be monitored for future reoccurrence.

Event Description

It was found that a small piece of the anchor had broken off and it potentially remains in the patient.

• Brand Name: AIR MENISCUS SYSTEM, CURVED
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 12857957
• MDR Text Key: 282193077
• Report Number: 0002936485-2021-00664
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 07613327375404
• UDI-Public: 07613327375404
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K153087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4720
• Device Catalogue Number: 4720
• Device Lot Number: 7002914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other