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

Model Number	4720
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
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 anchor broke during the procedure.All pieces were retrieved.
Event or Problem Description
It was reported that the anchor broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: implant broken during surgery.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.Process: dimple retaining feature not manufactured to specification.Implant anchor or needle not manufactured to specification.Stiffener not manufactured to specification.Application: user not familiar with device use.User excessively bends/kinks the needle h3 other text : 81.

• Brand Name: AIR MENISCUS SYSTEM, CURVED
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12191125
• Report Number: 0002936485-2021-00390
• Device Sequence Number: 2871104
• Product Code: GAT
• UDI-Device Identifier: 07613327375404
• UDI-Public: 07613327375404
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/30/2021

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 Model Number: 4720
• Device Catalogue Number: 4720
• Device Lot Number: 7002415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1