MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM PERC INSERT KIT FOR FIBERTAK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1.8MM PERC INSERT KIT FOR FIBERTAK
Health Effect - Clinical Codes	Laceration(s) (1946); Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/25/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 3/16/2022, it was reported by a facility representative via medwatch mailed in letter that a fragment of silver metal, part of the fibertak percutaneous insertion kit, ar-3610pk-3, was left inside the patient's during a right shoulder arthroscopy procedure on (b)(6) 2022.This was discovered after a follow up x-ray, due to patient complaint of right shoulder pain, related to trauma.The decision was made to operate, remove the piece, and also repair new tissue injury from related trauma.This procedure was a removal hardware posterior glenoid, repair of posterior labrum and repair new tear anterior labrum with fluoroscopic assistance.Date of revision surgery is unknown, no further information has been given at this time.

• Brand Name: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13994945
• Report Number: 1220246-2022-04687
• Device Sequence Number: 5317089
• Product Code: LXH
• UDI-Device Identifier: 00888867358225
• UDI-Public: 00888867358225
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Device Catalogue Number: AR-3610PK-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown