MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 20WX20L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 20WX20L
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	09/13/2018
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 device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient underwent a lapidus procedure in (b)(6) 2018 where a dynanite niti staple, ar-8719ds-2020 was implanted into her right foot.About four months post-op, the patient scheduled an appointment with her surgeon as the dynamite staple had broken.Additional information has been requested.Additional information provided (b)(4) 2018: original dos was (b)(6) 2018.The patient came to the surgeon with normal symptoms of pain related to hallux valgus.The revision was done (b)(6) 2018.The staple was removed.To be noted, according to the surgeon, the patient experienced a non union, and contributed to the breaking of the staple due to the fact that the joint was still in motion months after surgery.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 20WX20L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8030465
• Report Number: 1220246-2018-00722
• Device Sequence Number: 19157899
• Product Code: JDR
• UDI-Device Identifier: 00888867288164
• UDI-Public: 00888867288164
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: 12/31/2019
• Device Model Number: DYNANITE NITI STAPLE W/INSTRS 20WX20L
• Device Catalogue Number: AR-8719DS-2020
• Device Lot Number: 800980010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other