MAUDE Adverse Event Report: ARTHREX, INC. SPKD LGMNT STAPLE,6 MMX 20 MMSM; STAPLE, FIXATION, BONE

Model Number	SPKD LGMNT STAPLE,6 MMX 20 MMSM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a surgery a piece of the staple broke off during impacting.A piece remained in the patient's tissue.There was no harm for patient, operator or third party.The surgery was finished with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1006 spiked ligament staple batch number: 26062216 was received for evaluation.Visual inspection noted that one of the staple holding pins had broken off.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: SPKD LGMNT STAPLE,6 MMX 20 MMSM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17573822
• Report Number: 1220246-2023-07555
• Device Sequence Number: 8957282
• Product Code: JDR
• UDI-Device Identifier: 00888867002449
• UDI-Public: 00888867002449
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K943492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPKD LGMNT STAPLE,6 MMX 20 MMSM
• Device Catalogue Number: AR-1006
• Device Lot Number: 2228015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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
• Patient Sex: Unknown