MAUDE Adverse Event Report: ARTHREX, INC. PERC INSERT KIT FOR 3.0MM S-TAK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PERC INSERT KIT FOR 3.0MM S-TAK
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	06/22/2018
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.Per the facility, the device will not be 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 discovered during maude review and was received via fda medwatch letter (mw5078672) that a patient had undergone a right shoulder arthroscopy with inferior labral repair.Patient was doing well and began having increasing discomfort to this right elbow over a period of three days with significant pain and lump noted proximal to the antecubital fossa near the distal biceps tendon, with no report of injury, which prompted patient to go to the clinic.X-rays obtained in the clinic indicated obvious metal foreign body located within the right elbow.Patient was scheduled for foreign body removal from the right elbow.Op note indicated "the object was a metal nitinol guide-wire".Surgeon consulted with patient's parents.The following was also noted on the fda medwatch letter received by arthrex: event was reportable to the state of mn (4.Retention of a foreign object in a patient after surgery or other invasive procedure, excluding objects intentionally implanted as part of a planned intervention and object present prior to surgery that are intentionally retained).Device was a fragment from a percutaneous insertion kit for 3 mm suture-tak labral repair.Additional information obtained 8/17/2018: date of original surgery was (b)(6) 2018.Facility provided arthrex with a photo of the x-ray taken (b)(6) 2018 and a photo of the retained item next to a ruler after it was removed in the operating room (or) on (b)(6) 2018.Device per picture measures approximately 3.25 inches.Facility medwatch reporter states the facility is unable to send the actual retained wire to arthrex for evaluation.

• Brand Name: PERC INSERT KIT FOR 3.0MM S-TAK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7845653
• Report Number: 1220246-2018-00622
• Device Sequence Number: 2469034
• Product Code: LXH
• UDI-Device Identifier: 00888867024151
• UDI-Public: 00888867024151
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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 Model Number: PERC INSERT KIT FOR 3.0MM S-TAK
• Device Catalogue Number: AR-1934PI-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/05/2018
• 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