MAUDE Adverse Event Report: ARTHROCARE CORP. ENTACT SEPTAL STAPLER 3-PACK; SEPTAL STAPLER/ABSORBABLE STAPLES

Model Number	601-00100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a septoplasty, the entact septal stapler fell apart after the needle broke and popped out.There was a backup device available.No delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h6.The device reported, used in treatment, was not returned for evaluation.A picture of the device has been sent.Per the customer photos, there is no visual identification that the adhesive application into this device was performed.The relationship between the product and reported was established.A review of manufacturing records for the reported lot number 01908004 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.The complaint was verified and the root cause for this event was determined to be a manufacturing process error.

• Brand Name: ENTACT SEPTAL STAPLER 3-PACK
• Common Device Name: SEPTAL STAPLER/ABSORBABLE STAPLES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9519593
• Report Number: 3006524618-2019-00618
• Device Sequence Number: 18914092
• Product Code: OLL
• UDI-Device Identifier: 00817470006452
• UDI-Public: 00817470006452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2022
• Device Model Number: 601-00100
• Device Catalogue Number: 601-00100
• Device Lot Number: 01908004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1