MAUDE Adverse Event Report: INTEGRA YORK, PA INC. NAIL SPLITTER 4 STR; M13 - PODIATRY

Catalog Number 40-224

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems Laceration(s) (1946); Pain (1994); Injury (2348)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.The failure mode was confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.The instrument has a broken handle, there is blackening at the break site indicating that this started as stress fracture and with continued use and cleaning it caused the metal to break down and eventually causing it to break.The complaint report of damage has been confirmed; the root cause of the damage has not been identified as a workmanship or material deficiency.

Event Description

A customer reported to integra lifesciences that on (b)(6) 2018, a 40-224 nail splitter 4 str broke near the neck during a procedure which resulted in an injury to the doctor's hand.After the neck cracked, the broken piece entered the doctor¿s glove and inflicted a wound which was described as a 0.9cm cut on the inside of his right hand.The doctor reported due to the wound on the inside of his hand, he couldn't grip without pain.The doctor irrigated and cleaned the wound with normal saline solution then covered with triple antibiotic ointment and a bandage.The nippers broke in half with no separate piece.

Manufacturer Narrative

Additional information received on 25july2018, the surgeon's injury was superficial and did not require invasive medical intervention.It was treated with normal saline a topical antibiotic thus this report is not considered serious.

• Brand Name: NAIL SPLITTER 4 STR
• Type of Device: M13 - PODIATRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7772286
• MDR Text Key: 116735014
• Report Number: 2523190-2018-00101
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 40-224
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1