PALODENT PLUS FORCEPS
Report
- Report Number
- 2515379-2022-00056
- Event Type
- Malfunction
- Date Received
- November 14, 2022
- Report Date
- December 21, 2022
- Manufacturer
- DENTSPLY LLC
- Product Code
- DZN
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
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.
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.
IN THIS EVENT IT IS REPORTED THAT A PALODENT PLUS FORCEPS BROKE DURING USE. NO INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168523 | PALODENT PLUS FORCEPS | INSTRUMENTS, DENTAL HAND | DZN | DENTSPLY LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |