MAUDE Adverse Event Report: ARTHREX, INC. TIGERSTICK, #2 TIGERWIRE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	TIGERSTICK, #2 TIGERWIRE
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/30/2018
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.Attempts to receive additional information have received no response.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by the hospital that a patient experienced an infection after having arthrex parts implanted.At the time of the call the facility reporter was looking to obtain additional information regarding the implants, and did not have any other available information other than the arthrex parts that were used in the original procedure.The following arthrex parts were used during the original procedure: ar-2271 / lot: f185810 (acute ac repair kit); ar-7209t (tigerstick, #2 tigerwire); ar-2275 (obturator - instrument does not remain in patient).Update 5/23/19: several attempts have been made to obtain additional information with no response received.
Event or Problem Description
It was reported by the hospital that a patient experienced an infection after having arthrex parts implanted.At the time of the call the facility reporter was looking to obtain additional information regarding the implants, and did not have any other available information other than the arthrex parts that were used in the original procedure.The following arthrex parts were used during the original procedure: ar-2271 // lot: f185810, ar-7209t, and ar-2275.Update (b)(6) 2019: several attempts have been made to obtain additional information with no response received.Additional information obtained (b)(6) 2019: the original procedure took place on (b)(6) 2019.The procedure was a right shoulder open arthrotomy acromioclavicular joint, acromioclavicular dislocation repair and joint injection.The patient began experiencing symptoms six weeks post-op.The patient underwent a surgical wound washout (date unknown) and was treated with iv antibiotics and progressed to oral antibiotics.Sinus track drainage was done and a pico dressing was placed.One week later the wound was sutured closed and the issues are resolving.Cultures were done on (b)(6) 2019 and the patient was found to have propionibacterium.Additional information obtained (b)(6) 2019: the surgical wound washout was performed on (b)(6) 2019.The wound was sutured closed on (b)(6) 2019.
Additional Manufacturer Narrative
Follow-up submission to reflect event updates including the original date of the event and facility details.

• Brand Name: TIGERSTICK, #2 TIGERWIRE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8637000
• Report Number: 1220246-2019-01109
• Device Sequence Number: 11280987
• Product Code: GAT
• UDI-Device Identifier: 00888867041394
• UDI-Public: 00888867041394
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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 Model Number: TIGERSTICK, #2 TIGERWIRE
• Device Catalogue Number: AR-7209T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other