MAUDE Adverse Event Report: ARTHREX, INC. SABRE, SJ 2.0MM X 7CM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SABRE, SJ 2.0MM X 7CM
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a hand arthroscopy the device produced metal abrasion.The surgeon is not sure if fragments will remain inside the patient.The surgery was completed successfully with this device and there was no harm for patient, user or third party.
Additional Manufacturer Narrative
Complaint confirmed.The evaluation confirmed surface scratches on the od of the inner tube.This type of damage can result from excessive bending forces applied to the device during use.The inner and outer tubes rotated freely during testing with no abrasions noted, and the device met all dimensional specifications as received.

• Brand Name: SABRE, SJ 2.0MM X 7CM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7713361
• Report Number: 1220246-2018-00562
• Device Sequence Number: 1753885
• Product Code: GAT
• UDI-Device Identifier: 00888867041271
• UDI-Public: 00888867041271
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: SABRE, SJ 2.0MM X 7CM
• Device Catalogue Number: AR-7200SR
• Device Lot Number: 10175167
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/20/2018
• Patient Sequence Number: 1