MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY METZENBAUM PERMASHARP SCISSORS; SCISSORS, SURGICAL TISSUE, DENTAL

Model Number S5069

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

There is no relevant history.(b)(4).

Event Description

It was reported to hu-friedy mfg.(b)(6) that during an oral surgery procedure, the instrument broke in the patient's mouth.The broken tip was swallowed.

• Brand Name: HU-FRIEDY METZENBAUM PERMASHARP SCISSORS
• Type of Device: SCISSORS, SURGICAL TISSUE, DENTAL
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 n. rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO., LLC; 3232 n. rockwell st.; chicago IL 60618
• Manufacturer Contact: maria vrabie ; 3232 n. rockwell st.; chicago, IL 60618 ; 7738685676
• MDR Report Key: 6734390
• MDR Text Key: 80751439
• Report Number: 1416605-2017-00004
• Device Sequence Number: 1
• Product Code: EGN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2017

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: S5069
• Device Catalogue Number: S5069
• Device Lot Number: 0415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR