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

Model Number	4720
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
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 there was a breach in the sterile barrier.
Additional Manufacturer Narrative
Alleged failure: it was reported that the hospital staff noticed a puncture to the front corner of the foil packaging on the new air device.Ahs mdip # 8825.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) severe shipping conditions or 2) user mishandling.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacturing date is unknown.
Event or Problem Description
It was reported that there was a breach in the sterile barrier.

• 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: 11268655
• Report Number: 0002936485-2021-00056
• Device Sequence Number: 17094273
• Product Code: GAT
• UDI-Device Identifier: 07613327375404
• UDI-Public: 07613327375404
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2021

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: 7004435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1