MAUDE Adverse Event Report: DENTSPLY LLC PALODENT PLUS FORCEPS; INSTRUMENTS, DENTAL HAND

Catalog Number 659810

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that a palodent plus forceps broke during use.No injury occurred.

Manufacturer Narrative

Investigation findings: returned product one pair gen 2 forceps batch a081521 broken at the handle.Incoming/receiving documents for lot# a081521 forceps has been pulled, reviewed for this case.All incoming supplier documentation/certifications meet specifications as well as all visual, dimensional, and functional tests as per 0290-ip-ri-instruments.A total of (b)(4) forceps was received on 1/20/2022 and aql sampling size for visual inspection was n=86, and functional/dimensional n=86pcs and n=5 hardness testing, with all inspected forceps meeting all specifications per procedure.Incoming retains are kept from the initial batch of (b)(4) samples tested and therefore meet specifications as per 0290-ip-ri-instruments.

• Brand Name: PALODENT PLUS FORCEPS
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15790765
• MDR Text Key: 307279086
• Report Number: 2515379-2022-00056
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1