MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 25WX20L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 25WX20L
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed, one leg of the staple was found to be broken.Likely causes of the event include improper bone/joint prep, patient non-compliance and/ or non-union of the bones.
Event or Problem Description
It was reported that the clamp broke postoperative.Updated information 10-feb-2020: it was further reported that the clamp most likely broke during the processing after the surgery.Updated information 07-apr-2020: further information was provided that the article broke inside the patient.Therefore an additional surgery needed to be performed.It was further reported that the initial surgery was a tn-fusion and it was performed on (b)(6) 2019.The revision was performed on (b)(6) 2020.The surgery was finished successfully with a new device with the same part number.In addition a screw was used.
Additional Manufacturer Narrative
This supplemental submission is to correct the patient identifier in section a1 in the original submission.The typo error in section a1 of 1220246-2020-01809 showed an identifier of 379134-1-2 but should have been 37934-1-2.This is only reason for this supplemental submission.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 25WX20L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10009079
• Report Number: 1220246-2020-01809
• Device Sequence Number: 2968618
• Product Code: JDR
• UDI-Device Identifier: 00888867288171
• UDI-Public: 00888867288171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 11/30/2023
• Device Model Number: DYNANITE NITI STAPLE W/INSTRS 25WX20L
• Device Catalogue Number: AR-8719DS-2520
• Device Lot Number: 834588923
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 04/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other