MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 9WX7L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 9WX7L
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	07/08/2020
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 middle finger fusion procedure, the drill and guide included within the dynanite niti staple kit, ar-8717ds-0907, became stuck together and also within the patient's bone.The surgeon used needle pliers to wiggle the guide and drill out of the patient's bone.Once the drill and guide were removed from the patient and were able to be separated on the back table.The surgeon opted to place a plate from another manufacturer over the drill holes instead.
Additional Manufacturer Narrative
Complaint confirmed, evaluation of the drill bit and drill guide reveals circumferential abrasion and damage.A likely cause of the event is prying/leveraging the drill bit during use.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 9WX7L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10309641
• Report Number: 1220246-2020-01968
• Device Sequence Number: 19070583
• Product Code: JDR
• UDI-Device Identifier: 00888867287846
• UDI-Public: 00888867287846
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Expiration Date: 07/31/2023
• Device Model Number: DYNANITE NITI STAPLE W/INSTRS 9WX7L
• Device Catalogue Number: AR-8717DS-0907
• Device Lot Number: 820085012
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other