MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY MFG. CO., LLC; PERIOSTEAL

Model Number PFIWDS1

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

During the dental procedure, the instrument was used to check for mobility of tooth.This instrument's intended use is for reflecting and retracting the mucoperiosteum after incisions of the gingival tissue.No manufacturing defects were found during evaluation.There is a low level of return rates on this instrument.Hu-friedy does not track our devices, which are mostly low risk class 1 devices, by serial number, only a lot number which is tied to the date of manufacture.The product involved in the event does not have an expiration date.The device is not implanted.The device is not explanted.

Event Description

It was reported to us that the adverse event occurred while the patient was having extensive dental work.The dentist was using the instrument interproximally between tooth 3 and 4 to check for mobility when the device fractured.The dentist called the ent into the operating room, where an x-ray of skull and ct of head were ordered.The results confirmed a 1-2cm piece was lodged in the right posterior maxillary sinus.The ent removed the foreign body.General anesthesia was administered during the removal of the foreign body.The patient was kept overnight and discharged on (b)(6) 2016.

• Brand Name: HU-FRIEDY MFG. CO., LLC
• Type of Device: PERIOSTEAL
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 n rockwell st; chicago IL 60613
• Manufacturer (Section G): HU-FRIEDY MFG. CO., LLC; 3232 n rockwell st; chicago IL 60613
• Manufacturer Contact: maria vrabie ; 3232 n rockwell st; chicago, IL 60613 ; 7738685676
• MDR Report Key: 5651818
• MDR Text Key: 45150542
• Report Number: 1416605-2016-00003
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/29/2016

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: PFIWDS1
• Device Catalogue Number: PFIWDS1
• Device Lot Number: 1014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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): Hospitalization
• Patient Age: 16 YR
• Patient Weight: 47