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
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9141746
• Report Number: 1220246-2019-01338
• Device Sequence Number: 19773866
• Product Code: LXH
• UDI-Device Identifier: 00888867003774
• UDI-Public: 00888867003774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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 Model Number: BIRDBEAK, 2.75MM, 22 DEGREE UP TIP
• Device Catalogue Number: AR-11890
• Device Lot Number: 22585
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other