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

Catalog Number	4723
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: thread of air all-inside meniscal repair system torn off during medical procedure on (b)(6) 2023.Delay apparently caused by reporter as intake via fax was sent and reached cic on friday october 12, 2023.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
Based on investigation results, the anchor was broken.Based on this the anchor broke during procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: thread of air all-inside meniscal repair system torn off during medical procedure on (b)(6) 2023.Delay apparently caused by reporter as intake via fax was sent and reached cic on friday october 12, 2023.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be 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.
Event or Problem Description
Based on investigation results, the anchor was broken.Based on this the anchor broke during procedure.All pieces were retrieved.

• Brand Name: AIR+ MENISCAL SYSTEM - CURVED DOWN
• Common Device Name: 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18699508
• Report Number: 0002936485-2024-00127
• Device Sequence Number: 17979983
• Product Code: GAT
• UDI-Device Identifier: 07613327482072
• UDI-Public: 07613327482072
• 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): 09/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4723
• Device Lot Number: 7010929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 09/03/2024
• 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 Age: 45 YR
• Patient Sex: Male