MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH M-CONNECTOR PKG. ASS; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	OM-8007
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that item was being used and as the jaw was being closed, the item came away.No patient injuries reported.
Additional Manufacturer Narrative
The returned instrument, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the returned devices and the reported incident.Visual inspection shows a deployed smartstich m connector with a detached upper jaw.The jaw was not returned with the device.No manufacturing anomalies could be visually identified.The returned m-connector was adapted in to a smart stich device (om-8000).The lock function has been tested and performed as intended.The needles have been selected and could be fired as specified.The complaint was verified and the root cause could be determined due to a mechanical component failure.

• Brand Name: SMARTSTITCH M-CONNECTOR PKG. ASS
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8005197
• Report Number: 3006524618-2018-00560
• Device Sequence Number: 13811284
• Product Code: GAT
• UDI-Device Identifier: 00817470005714
• UDI-Public: 00817470005714
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: No Information
• Device Expiration Date: 02/21/2019
• Device Catalogue Number: OM-8007
• Device Lot Number: 1136529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1