MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PERFECTPASSER SUTURE CARTRID; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	OM-8176
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the tip of the smartstitch suture cartridge broke off with no obvious pressure to cause same.The surgeon was unable to find the tip and the concern was that it could be in the patient joint.They washed the joint in an effort to reduce that risk which caused a 15 min delay.A backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
The reported device was returned to the local office and intended to be used for treatment, but was not made available to the designated team for investigation.We cannot determine if there is a relationship between the device and the incident because the product was returned to the local office; however, was not made available to the designated team for evaluation.Visual inspection and functional testing could not be performed because the device in question was returned to the local office; however, not made available to the designated team for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.If / when the device is returned to the designated team for evaluation, this investigation will be reopened.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.

• Brand Name: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8099944
• Report Number: 3006524618-2018-00609
• Device Sequence Number: 1721306
• Product Code: GAT
• UDI-Device Identifier: 00817470005820
• UDI-Public: 00817470005820
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2019

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 Expiration Date: 09/28/2020
• Device Catalogue Number: OM-8176
• Device Lot Number: 2006601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 02/15/2019
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 12/10/2018; 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1