MAUDE Adverse Event Report: ARTHREX, INC. 3.9MM KNOTLESS CORKSCREW, PEEK; SCREW, FIXATION, BONE

Model Number	3.9MM KNOTLESS CORKSCREW, PEEK
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	09/09/2019
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient underwent a rotator cuff repair procedure (date of surgery currently unknown).The patient re-tore their rotator cuff and had a revision rcr on (b)(6) 2019.During the revision it was discovered that the patient's cuff was irreparable and the surgeon switched to a superior capsule reconstruction.Due to the soft bone quality the following arthrex parts being used would not stay seated in the bone: ar-1938bc // lot: 10265961 // qty.: 1, ar-1938bc // lot: f189852 // qty.: 1.The rep stated the procedure was arthroscopic.It is unknown if arthrex parts were used during the original rcr; however, no arthrex products were removed during the revision on (b)(6) 2019.The rep stated there were no further issues with any other arthrex products during the case.The husband of the patient called the surgeon on (b)(6) 2019, stating the lateral portal wound was draining fluid and they were worried about infection.The patient came in for a follow-up visit with the surgeon on (b)(6) 2019 to have the wound looked at.The rep stated they cannot confirm if cultures were taken.At the moment no revision procedure is scheduled, but the patient has been scheduled to come back for a follow up visit.However, the rep stated they were not informed of the specific date of the follow-up, or given any further details.The following arthrex devices were implanted during the (b)(6) 2019 procedure, and remain implanted in the patient: aflex301 // id #: 1912747-0106, ar-1938bc // f189852 // qty.: 1, ar-1941ps // lot: 10247538 // qty.: 1, ar-1941ps // lot: 10248921 // qty.: 1, ar-3638 // lot: 10328308 // qty.: 1.*additional information received on 10/04/2019: the rep reported there was no infection found, and they contacted the manufacturer of aflex301 regarding the matter.Additional information has been requested.*additional information received on 10/08/2019: the patient started experiencing clear drainage on (b)(6) 2019.The patient's symptoms were treated with antibiotics (clindamycin).The rep confirmed the graft implanted (aflex301 // id #: 1912747-0106) was purchased by the facility directly from the manufacturer.It was reported that cultures were not taken, and there are no available pictures.

• Brand Name: 3.9MM KNOTLESS CORKSCREW, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9179207
• Report Number: 1220246-2019-01350
• Device Sequence Number: 10874611
• Product Code: HWC
• UDI-Device Identifier: 00888867270794
• UDI-Public: 00888867270794
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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 Expiration Date: 09/30/2023
• Device Model Number: 3.9MM KNOTLESS CORKSCREW, PEEK
• Device Catalogue Number: AR-1941PS
• Device Lot Number: 10247538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/11/2019
• 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