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

Catalog Number	4722
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at the anchor.The anchor broke in half off the suture and the anchor was floating in the joint.It was thought that the broken pieces were not retrieved.There was a 45 minute delay.
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 implant at the anchor.The anchor broke in half off the suture and the anchor was floating in the joint.It was thought that the broken pieces were not retrieved.There was a 45 minute delay.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: anchor broken in joint probable root cause: design dimple retaining feature does not retain implant or retains implant with excessive force needle/implant stack up interference stack up interference for deployment length/width stack up interference for component size/diameter stiffener feature distorted and retains implant with excessive force inadequate handle assembly design inadequate raw material needle bend angle too large application user not familiar with device use user excessively bends/kinks the needle the reported 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, 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: 18879043
• Report Number: 0002936485-2024-00209
• Device Sequence Number: 7839239
• Product Code: GAT
• UDI-Device Identifier: 07613327482065
• UDI-Public: 07613327482065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 4722
• Device Lot Number: 7012624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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