MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-24 for RETAINING 2.5MM HEX DRIVE R LONG RHL2.5 manufactured by Zimmer Dental.
[182961258]
One retaining 2. 5mm hex drive r long (rhl2. 5) and one impl tapered scr-v sbm 4. 7mm 4. 5mm 11. 5mm (tsvwb11) were returned for investigation. Visual inspection of the as returned products identified signs of use on the tool, dried blood and bone on the implant and no apparent fracture. Functional testing was performed for the returned products, which determined the devices failed functional testing and the reported event (does not disengage), was recreated as the devices stuck together when engaged. Functional testing to recreate the reported event (fracture) could not be performed due to the nature of the devices & event. The reported device (rhl2. 5) is associated with ca2203, scar14023 and hhe2014-120. This item/lot combination was included in recall zfa2014-120. As distribution of subject product has been discontinued, no further corrective actions are required at this time. No pre-existing conditions were noted on the per, the patient had unknown bone density. The reported devices were used on an unknown tooth and were used for an unknown duration. Dhr reviews were completed for the subject lot numbers (62735177). It was confirmed that all operations and inspections were executed as per applicable procedure. No deviations or non-conformances, which could have caused or contributed to the reported events were noted as part of the dhrs. Lots were inspected and passed all acceptance criteria by qa. Complaint history review was performed for the tool's reported lot number (62735177) for similar events and one other complaint was identified. November post market trending was reviewed and there were no actionable events or corrective actions for the reported events (does not disengage, fracture) or devices (rhl2. 5 & tsvwb11). Therefore, based on the available information, device malfunction did occur for both reported devices and the reported event (does not disengage) was confirmed for both devices as the devices stuck when engaged, while the reported event (fracture) of the driver was unconfirmed as no fracture was identified during visual inspection. Zimmer biomet complaint (b)(4). Age: not provided. Patient weight: not provided. Initial reporter fax number: not provided.
Patient Sequence No: 1, Text Type: N, H10
[182961259]
It was reported that a driver (rhl2. 5) got stuck within the implant and then fractured. Doctor was able to complete the procedure using another implant. Upon investigation of the returned device, fractured driver was unable to be confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00166 |
| MDR Report Key | 9629156 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-09-27 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2014-06-05 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SUSANNE TAYLOR |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5617766700 |
| Manufacturer G1 | ZIMMER DENTAL |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETAINING 2.5MM HEX DRIVE R LONG |
| Generic Name | DENTAL DRIVER |
| Product Code | NDP |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2019-10-28 |
| Catalog Number | RHL2.5 |
| Lot Number | 62735177 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER DENTAL |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |