MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, STAPLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER, STAPLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
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 knee procedure, the tip of the staple driver, ar-1005, broke.The tip of the driver was retrieved and the case was completed with no adverse effect to the patient.No further details.

• Brand Name: DRIVER, STAPLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11302063
• Report Number: 1220246-2021-02561
• Device Sequence Number: 19767494
• Product Code: LXH
• UDI-Device Identifier: 00888867002401
• UDI-Public: 00888867002401
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRIVER, STAPLE
• Device Catalogue Number: AR-1005
• Device Lot Number: 189879
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other