MAUDE Adverse Event Report: ARTHREX, INC. SUPERMX COMPRESSION STAPLE, 18W X 18L; STAPLE, FIXATION, BONE

Model Number SUPERMX COMPRESSION STAPLE, 18W X 18L

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2021

Event Type  malfunction  

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 Description

It was reported that during arthroscopy surgery the clip did break off intraoperative.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.

Manufacturer Narrative

Complaint confirmed.Two unpackaged ar-8719mx01818 were received for investigation.Visual inspection identified that both staples had broken at one end, with a single leg returned measuring approximately 0.61".The other fragment was not returned for analysis.Both staple bodies were assessed using digital micrometer id: 224 and were found to meet design specifications.One of the two staple bodies presented surface damage/chipping across its top width.The cause of the event remains undetermined.Information as to the method of bone preparation, as well as the bone quality encountered, was not provided.

• Brand Name: SUPERMX COMPRESSION STAPLE, 18W X 18L
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12076060
• MDR Text Key: 258868820
• Report Number: 1220246-2021-03330
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00888867300941
• UDI-Public: 00888867300941
• Combination Product (y/n): N
• PMA/PMN Number: K203180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPERMX COMPRESSION STAPLE, 18W X 18L
• Device Catalogue Number: AR-8719MX-1818
• Device Lot Number: 009912816
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other