MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 18WX18L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 18WX18L
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/16/2018
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 requested/is expected but has not returned for evaluation.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 leg on the ar-8719ds-1818, dynanite nitinol staple implant system 18w x 18l is broken.The rep stated that it is unknown how or when the implant leg broke.The patient came back for a follow up visit and the device was discovered broken on the x-ray that was taken.The rep stated that the ar-8719ds-1818 remains implanted in the patient, and that there is not any record of patient discomfort.The rep reported that the surgeon is discussing a hardware removal surgery.Additional information requested regarding date of removal.Additional information received on 09/12/2018: the rep confirmed that the original procedure took place on (b)(6) 2018.The revision surgery has been scheduled for (b)(6) /2018.Additional information received on 09/14/2018: the rep confirmed that a hardware removal and revision evans procedure with illiac crest plate fixation took place on (b)(6) 2018.The revision was completed by the same surgeon who performed the original surgery, and took at the same facility where the original surgery was performed.The following arthrex part and lot numbers were explanted during the revision surgery on (b)(6) 2018: 1.Ar-8719ds-1818 / lot: 800980008.2.Ar-8942w-1810 / lot: 4210.The following arthrex part and lot numbers were implanted during the revision surgery on (b)(6) 2018: 1.Ar-8942r-l / lot: 10123947.2.Ar-8935-20 / lot: 10001844.3.Ar-8935-22 / lot: 10001427.4.Ar-8935l-20 / lot: 1336554.5.Ar-8935l-22 / lot: 191236.Additional information received on 09/20/2018: there were two arthrex representatives present during the revision surgery.The broken staple was removed with no new implant used in the same site.The rep confirmed that the bone quality was good.During the revision surgery the surgeon performed another procedure in the calcaneus using an h plate.An allosync 1 cc graft was used.
Additional Manufacturer Narrative
Complaint confirmed.Dimensional and material analysis results confirmed the ar-8719ds-1818 met all as-received conditions.Visual evaluation revealed that approximately 10.92mm of one of the staple legs had broken off of the device prior to receipt for investigation.This event is most likely caused by user mechanical damage to device, such as hitting the device with another device, prying/leveraging, or excessive bending forces applied during use.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 18WX18L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7923115
• Report Number: 1220246-2018-00684
• Device Sequence Number: 1639860
• Product Code: JDR
• UDI-Device Identifier: 00888867288140
• UDI-Public: 00888867288140
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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 18WX18L
• Device Catalogue Number: AR-8719DS-1818
• Device Lot Number: 800980008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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