MAUDE Adverse Event Report: OTTO RUETTGERS GMBH & CO. KG HU-FRIEDY 15C STERILE SCALPEL BLADE, STAINLESS STEEL

Model Number 40-815C

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2017

Event Type  Injury  

Event Description

It was reported to (b)(4) that the dentist was performing an implant procedure when the instrument broke in the patient's mouth.The patient swallowed the tip.

Event Description

It was reported to hu-friedy mfg.Co., llc that the dentist was performing an implant procedure when the instrument broke in the patient's mouth.The patient swallowed the tip.This follow-up report is to correct initial report # 3009968482-2017-00001.Initially, it was incorrectly reported that the device involved in the event had been returned to the manufacturer.However, while other devices from the same lot were returned to the manufacturer for evaluation, the device involved in the incident was not returned.

• Brand Name: HU-FRIEDY 15C STERILE SCALPEL BLADE, STAINLESS STEEL
• Type of Device: STERILE SCALPEL BLADE
• Manufacturer (Section D): OTTO RUETTGERS GMBH & CO. KG; roonstr. 17-19; solingen, nordrhein-westfalen 42699 ; GM 42699
• MDR Report Key: 6655445
• MDR Text Key: 78021044
• Report Number: 3009968482-2017-00001
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/20/2017,07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 08/01/2020
• Device Model Number: 40-815C
• Device Catalogue Number: 40-815C
• Device Lot Number: 3320
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/20/2017
• Distributor Facility Aware Date: 05/22/2017
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR