MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-07-26 for DEPTH GAGE 2.0/2.4 45MM LONG N/A 01-9125 manufactured by Biomet Microfixation.
[81111674]
Device product code: eil. Current information is insufficient to permit a valid conclusion about the cause of this event; a follow-up report will be sent upon completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[81111675]
It was reported the tip of the depth gauge broke in the patient's mouth. The surgeon tried to remove the piece but was not successful. Less than one millimeter of the tip remained in the right side of the patient's mandible. The surgeon stated there will be no revision to remove the tip as they feel the tip does not present any danger to the patient. There was no delay to the procedure that exceeded ten minutes.
Patient Sequence No: 1, Text Type: D, B5
[114366162]
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. The product was returned without packaging. The instrument was visually evaluated and found to have a section of the depth gauge spike broken off. When the spike is slid, the remaining portion of the spike begins to exit the guide at 18 mm, indicating the section of the tip broken off was roughly 18 mm in length. The instrument is in good overall cosmetic condition with scratches and normal signs of wear from use; slight discoloration was observed on the handle and the interface between the spike and slide. The manufacturing history was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Investigation results concluded that the reported event was due to excessive force applied by the user. The spike is delicate as the tip tapers from. 034? To. 022? Thick. A summary of the investigation will be sent to the complainant conveying proper surgical technique and use of the device. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Based on the product evaluation, the following fields were updated: report date to reflect the date of this report. Date received by mfr to reflect the date the product evaluation as completed. Type of reports to reflect this is follow up report #1. If follow-up, what type? To reflect the reason for the follow-up report. Device evaluated by mfr? To reflect the product evaluation is completed. (b)(4). Additional mfr narrative to reflect relevant additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2017-00594 |
| MDR Report Key | 6745294 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-07-26 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-11-17 |
| Device Manufacturer Date | 2009-01-22 |
| Date Added to Maude | 2017-07-26 |
| 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 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPTH GAGE 2.0/2.4 45MM LONG |
| Generic Name | GAUGE, DEPTH, INSTRUMENT, DENTAL |
| Product Code | EIL |
| Date Received | 2017-07-26 |
| Returned To Mfg | 2017-06-10 |
| Model Number | N/A |
| Catalog Number | 01-9125 |
| Lot Number | 535681 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Deathisabilit | 2017-07-26 |