MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE; ACCESSORIES, ARTHROSCOPIC

Model Number	SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/15/2020
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 during a shoulder arthroscopy the tip of the device broke off.The surgeon decided to not remove the fragment as removing the tip would cause more risk to the patient.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The initial allegation states that the tip of the device broken off.This was partially confirmed as the manufacturer¿s evaluation revealed the distal tip of the sheath is damaged and only a small part of the distal tip is broken off.The whole sheath shows strong traces of usage.There are deep scratches, dents and deformations in the outer tube of the sheath at the distal end.The strong deformation which could be detected on the distal end indicate that the damages were caused by customer damage by applying too much force on the sheath during usage time or by a handling error.Most probably, the sheath was hit or fell down by mistake or the distal end of the sheath got in contact with another sharp instrument.

• Brand Name: SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10443186
• Report Number: 1220246-2020-02087
• Device Sequence Number: 2452452
• Product Code: NBH
• UDI-Device Identifier: 00888867206984
• UDI-Public: 00888867206984
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE
• Device Catalogue Number: AR-3373-5002
• Device Lot Number: 1460192
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other