MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-07 for ELEVATOR #77R N/A 09-0313 manufactured by Biomet Microfixation.
[138129022]
(b)(4). Complaint sample was evaluated and the reported event was confirmed. The customer reported one elevator; however there were five (5) elevator #77r (part# 09-0313) returned. No response has been received at this time regarding the additional elevators. Two (2) of these were of lot 120417k17 and three (3) were of lot 042518d18. All of the elevators exhibited fractured tips. Device history records (dhrs) were reviewed and no discrepancies were found. There are no indications of manufacturing defects. Investigation results concluded that the reported event was due to the instruments experienced force in excess of what they were designed to encounter. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00782-1.
Patient Sequence No: 1, Text Type: N, H10
[138129024]
It was reported the elevator broke. An x-ray was performed to ensure removal of the broken piece; there was a delay of 16-30 minutes. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00149 |
| MDR Report Key | 8400094 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2018-05-11 |
| Date Added to Maude | 2019-03-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVATOR #77R |
| Generic Name | ELEVATOR, SURGICAL, DENTAL |
| Product Code | EMJ |
| Date Received | 2019-03-07 |
| Returned To Mfg | 2019-02-13 |
| Model Number | N/A |
| Catalog Number | 09-0313 |
| Lot Number | 042518D18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-07 |