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	11/15/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the device was inserted it, loaded and fired once then loaded and fired the second time.When the surgeon withdrew the device from the joint there was a detached suture and nothing else.They searched for the anchors in the joint and could only find a small piece of suture.
Event or Problem Description
It was reported that the device was inserted it, loaded and fired once then loaded and fired the second time.When the surgeon withdrew the device from the joint there was a detached suture and nothing else.They searched for the anchors in the joint and could only find a small piece of suture.
Additional Manufacturer Narrative
Alleged failure: we opened a ref 4723 air+ cd.Dr (b)(6) inserted it, loaded and fired once then loaded and fired the second time.When he withdrew the air+ from the joint there was a detached suture and nothing else.We searched for the plegetts in the joint and could only find a small piece of suture.We opened a ref 4722 air+ cu and continued the meniscal repair.The product was retrieved and decontaminated for return.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) use of excessive force, 2) user not familiar with device use.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 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: 18323203
• Report Number: 0002936485-2023-01249
• Device Sequence Number: 15224156
• Product Code: GAT
• UDI-Device Identifier: 07613327482072
• UDI-Public: 07613327482072
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4723
• Device Lot Number: 7010170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 07/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown