MAUDE Adverse Event Report: KATENA PRODUCTS, INC KATENA PRODUCTS, INC; CRAWFORD RETRIEVING HOOK

Model Number	K7-2623
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual and optical microscopy examination of the returned instrument confirmed that the tip was not present and not returned to the manufacturer.The returned instrument had many scratches and gouges on the surfaces at the hook area.In addition, more serious damage observed was the rounding / flattening of right angles and the bent area of the inner hook gap arc which suggests exposure to excessive force(s).These damages were most likely induced by entanglement with other devices during transporting, cleaning and sterilization processes.The ifu includes the following pertinent statements, "it is very important to carefully examine each instrument for breaks, cracks or malfunctions before use.Do not use damaged instruments." review of the manufacturer's complaint handling system database confirmed this to be the first report of this nature for this device (k7-2623).The instrument has been in commercial distribution for several years without incident or complaint.The site contact indicated that there was no injury to the patient and no prolonged hospitalization required.An otolaryngologist examined the patient at a follow-up visit and found no evidence of retained metal, no further recommendations.
Event or Problem Description
As provided by the site: plastic repair of left canaliculus, probing dilation and silastic tube intubation of the left nasolacrimal drainage system, excision of canalicular abscess and diverticulum with over sewing and closure with a microscope.After a guibor tube was passed, the tip of the metal rod was guided out with the crawford retrieval hook.Upon removing the metal rod, the tip of the crawford retrieval hook was noted to break off.Attempts were made to extract this directly but were unsuccessful.Visualization of the piece was made with a nasal endoscope.The area was suctioned numerous times.The piece was not retrieved in the suction canister trap.The metal piece was gone upon re-visualization of the area.Patient was discharged home and referred to an otolarygologist for further evaluation.Follow-up visit: the otolaryngologist has seen the patient and has no further recommendations.He found no evidence of retained metal during his exam.

• Brand Name: KATENA PRODUCTS, INC
• Common Device Name: CRAWFORD RETRIEVING HOOK
• Manufacturer (Section D): KATENA PRODUCTS, INC; 6 campus drive, suite 310; parsippany NJ 07054
• MDR Report Key: 9497691
• Report Number: 2242450-2019-00002
• Device Sequence Number: 19578550
• Product Code: HNL
• UDI-Device Identifier: 00841668108840
• UDI-Public: 00841668108840
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: K7-2623
• Device Catalogue Number: K7-2623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2019
• Event Location: Ambulatory Surgical Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2019
• 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