MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIR+ MENISCAL SYSTEM - CURVED UP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLEN

Catalog Number	4722
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
Per investigation results, the anchor was found to be broken.Based on this, the anchor broke during procedure.
Event or Problem Description
Per investigation results, the anchor was found to be broken.Based on this, the anchor broke during procedure.
Additional Manufacturer Narrative
Alleged failure: air+ did not trigger/release.Replacement was available.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) user not familiar with device use, 2) use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: AIR+ MENISCAL SYSTEM - CURVED UP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLEN
• 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: 17889991
• Report Number: 0002936485-2023-01016
• Device Sequence Number: 20576997
• Product Code: GAT
• UDI-Device Identifier: 07613327482065
• UDI-Public: 07613327482065
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4722
• Device Lot Number: 7010926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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