MAUDE Adverse Event Report: KATENA PRODUCTS, INC RHEIN MEDICAL; SHEPPARD TOMAHAWK CHOPPER RIGHT HAND DOMINANT

Model Number	08-14527
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual examination of the returned instrument confirmed that the tip had broken off and that the break occurred at a location that would require excessive force to break.This excessive force is more than would be expected during normal cataract phacoemulsification surgery.This suggests that the instrument was most likely exposed to excessive force prior to its use in surgery, whereby, the structural integrity of the metal was compromised and ultimately contributed to the breakage.Review of the manufacturer's complaint handling system database confirms this to be the first report of this nature for this device (model number 08-145278).The instrument has been in commercial distribution for several years without incident or complaint.The surgeon reported that he took the tip our during the surgery, that there was no injury to the patient and no prolonged hospitalization required.
Event or Problem Description
During phacoemulsification cataract surgery the tip of an ophthalmic chopper broke off in the patient's eye.The surgeon removed the broken tip during the surgery.

• Brand Name: RHEIN MEDICAL
• Common Device Name: SHEPPARD TOMAHAWK CHOPPER RIGHT HAND DOMINANT
• Manufacturer (Section D): KATENA PRODUCTS, INC; 6 campus drive, suite 310; parsippany NJ 07054
• MDR Report Key: 9176998
• Report Number: 2242450-2019-00001
• Device Sequence Number: 409278
• Product Code: HND
• UDI-Device Identifier: 00852979003397
• UDI-Public: 00852979003397
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 08-14527
• Device Catalogue Number: 08-14527
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/07/2019
• Event Location: Ambulatory Surgical Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention