MAUDE Adverse Event Report: ARTHREX, INC. PIN DRIVER ATTACHMENT, 0-3.2MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	PIN DRIVER ATTACHMENT, 0-3.2MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device has metal abrasion.There was no harm for patient, operator or third party reported.No further information received.Update 04-may-2023 (b)(6): further information revealed that this incident occurred during an osteosynthesis for radial head and crown process fracture at the left elbow.The metal abrasion occurred from the clamping fixture for kirschner wires.Clearly visible metal particles fell into the surgical site, but these could be completely removed macroscopically by mechanical cleaning/rinsing.Apart from the slight prolongation of the operating time (less than 15 minutes), there were no damage/negative consequences for the patient.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.Update 05-may-2023 (b)(6): further information revealed, that the surgeon was not aware at this time that the particles are metal abrasions.The surgeon thought the particles were dried blood, but the surgical site was rinsed out to make sure nothing remained in the patient.
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
Additional information: d9, g3, h3, h6.Complaint is confirmed.Event description: it was reported that the device has metal abrasion.Further information revealed that this incident occurred during an osteosynthesis for radial head and crown process fracture at the left elbow.The metal abrasion occurred from the clamping fixture for kirschner wires.Clearly visible metal particles fell into the surgical site, but these could be completely removed macroscopically by mechanical cleaning/rinsing.Apart from the slight prolongation of the operating time (less than 15 minutes), there were no damage/negative consequences for the patient.The reported event was confirmed.The manufacturers evaluation revealed damages at two axial bearings in the shaft which caused the metal abrasion.Furthermore, a spring which holds the pin has slipped out of position.The most likely cause of this condition can be too much load during use.

• Brand Name: PIN DRIVER ATTACHMENT, 0-3.2MM
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 17017770
• Report Number: 1220246-2023-06800
• Device Sequence Number: 17934195
• Product Code: HWE
• UDI-Device Identifier: 00888867102163
• UDI-Public: 00888867102163
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 10/18/2024

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: PIN DRIVER ATTACHMENT, 0-3.2MM
• Device Catalogue Number: AR-400PD
• Device Lot Number: 10297647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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