MAUDE Adverse Event Report: ARTHREX, INC. BIRDBEAK, 2.75MM, 22 DEGREE UP TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number BIRDBEAK, 2.75MM, 22 DEGREE UP TIP

Device Problems Material Protrusion/Extrusion (2979); Packaging Problem (3007)

Patient Problem Injury (2348)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined.The root cause of the event could not be determined from the information available.

Event Description

It was reported by the arthrex service complaints tech ii, that an incident occurred on (b)(6) 2019 involving a complaint device for case (b)(4) that was being received at the arthrex service center (aci).While the service complaints tech ii was receiving the complaint device, which was packaged in a box, the individual was injured.The employee was cut by the complaint device when it was unnoticed that the complaint device tip was sticking through the shipping box.The device was shipped to arthrex by the medical facility which packaged the item.The complaint device, ar-11890, (birdbeak 2.75mm 22 degree up tip) is a sharp object and should have been properly packaged as such prior to shipping.

Manufacturer Narrative

Complaint confirmed.The product technician was injured by the complaint device protruding from the packaging.A most likely cause for this event is improper packaging by the customer site.

• Brand Name: BIRDBEAK, 2.75MM, 22 DEGREE UP TIP
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9141746
• MDR Text Key: 165117627
• Report Number: 1220246-2019-01338
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867003774
• UDI-Public: 00888867003774
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BIRDBEAK, 2.75MM, 22 DEGREE UP TIP
• Device Catalogue Number: AR-11890
• Device Lot Number: 22585
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other