MAUDE Adverse Event Report: ARTHREX, INC. PNCH, LG 15 UP TP, 2.75 STR, W/FLUSHPORT; MANUAL INSTR, GENERAL SURGICAL

Model Number PNCH, LG 15 UP TP, 2.75 STR, W/FLUSHPORT

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  malfunction  

Event Description

It was reported that during a knee arthroscopy the pin loosened from the joint.Nothing broke off inside the patient.There was no harm for patient, operator or third party.The surgery was finished successfully and the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.

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.

Manufacturer Narrative

Additional information: d9, g3, h6 complaint confirmed.One unpackaged ar-11250f batch 10484146 was received for investigation.The returned device was visually inspected, and it was noted that the jaw pin was missing.Also, it was noted that the shaft of the instrument was bent.The functional test found that the jaw doesn¿t move when the finger is pressed.The reported condition is most likely caused by overstressing a device damaged naturally and inevitably because of normal wear or aging.Device manufacture date 2019.

• Brand Name: PNCH, LG 15 UP TP, 2.75 STR, W/FLUSHPORT
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: 17773181
• MDR Text Key: 323722344
• Report Number: 1220246-2023-07941
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PNCH, LG 15 UP TP, 2.75 STR, W/FLUSHPORT
• Device Catalogue Number: AR-11250F
• Device Lot Number: 10484146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1