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

Model Number	4722
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
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 during procedure the 2 small peek implants broke in two.The pieces were potentially unable to be retrieved.
Event or Problem Description
It was reported that during procedure the 2 small peek implants broke in two.The pieces were potentially unable to be retrieved.
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: broke in two.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 (g11).User excessively bends/kinks the needle (g26).The reported failure mode will be monitored for future reoccurrence.Note: the investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: sales rep reported by phone that : "during procedure with the meniscal suture, the 2 small peek implant broke in two, no abnormal force was use on the implant." 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.

• 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: 17295349
• Report Number: 0002936485-2023-00681
• Device Sequence Number: 6096217
• Product Code: GAT
• UDI-Device Identifier: 07613327482065
• UDI-Public: 07613327482065
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Model Number: 4722
• Device Catalogue Number: 4722
• Device Lot Number: 7009333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 02/21/2024
• 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