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

Model Number	DYNANITE NITI STAPLE W/INSTRS 9WX7L
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/7/2022, it was reported by a sales rep via email that a ar-8717ds-0907, dynanite niti staple w/instrs 9wx7l, was reported that on the first pass of the drill bit, it became stuck in the drill guide.It can rotate but can not be extracted.This was discovered during a 1st metatarsal cheilectomy and akin osteotomy.The patient was involved.To complete the procedure, a 1.6mm k-wire was used to prepare the hole for the dynanite staple second leg.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the blocked drill bit stuck in the drill guide.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15484281
• Report Number: 1220246-2022-05542
• Device Sequence Number: 17446185
• Product Code: JDR
• UDI-Device Identifier: 00888867287846
• UDI-Public: 00888867287846
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: DYNANITE NITI STAPLE W/INSTRS 9WX7L
• Device Catalogue Number: AR-8717DS-0907
• Device Lot Number: 1256115608
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 03/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown