MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY #9 DEAN SCISSORS; SCISSORS, SURGICAL TISSUE, DENTAL

Model Number S9

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

There is no relevant history.Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number or udi, only by a lot number, which is tied to the date of manufacture.In this instance, the lot number is was not provided by the initial reporter.The device involved in the event does not have an expiration date.The device is not implanted, therefore implant/explant dates are not applicable.No known concomitant medical products and therapy dates.Pma/510(k) is not applicable.The device manufacture date is unknown.

Event Description

It was reported to hu-friedy co., llc that during an oral surgery procedure, the instrument broke in the patient's mouth.The broken tip was swallowed.The broken tip was later retrieved from the small intestine using an endoscope.

Manufacturer Narrative

The device in question was returned to hu-friedy mfg.Co., llc after the initial report was filed.Analysis of the returned instrument revealed that it was past its life expectancy.Lot number has been updated.Device was returned to manufacturer.This is a follow-up report this follow-up report provides additional information and device evaluation.Device was returned to manufacturer.Device manufacture date has been provided.H6 - method, result and conclusion codes have been updated.

• Brand Name: HU-FRIEDY #9 DEAN SCISSORS
• Type of Device: SCISSORS, SURGICAL TISSUE, DENTAL
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 n. rockwell st.; chicago IL 60618
• MDR Report Key: 7481761
• MDR Text Key: 107186486
• Report Number: 1416605-2018-00003
• Device Sequence Number: 1
• Product Code: EGN
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

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
• Device Operator: Dentist
• Device Model Number: S9
• Device Catalogue Number: S9
• Device Lot Number: 0510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 04/02/2018
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 42 YR
• Patient Weight: 82