MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-17 for DEPTH GAUGE N/A SP-1248 manufactured by Biomet Microfixation.
[60687493]
Device product code: eil. The user facility is foreign; therefore a facility medwatch report will not be available. The product was requested but will not be returned for an evaluation. Because the lot number is unknown, the device history records could not be pulled and reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[60687494]
It was reported that a depth gauge broke into two pieces during a procedure. It is reported that the breakage was due to being worn out and over used. It is reported the two pieces did not fall into the patient. It is reported that no delay over thirty minutes occurred as a result of this event. It is reported the procedure was completed with a spare depth gauge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2016-00679 |
| MDR Report Key | 6110069 |
| Date Received | 2016-11-17 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-10-24 |
| Date Mfgr Received | 2016-10-25 |
| Date Added to Maude | 2016-11-17 |
| 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 | 0 |
| Brand Name | DEPTH GAUGE |
| Generic Name | DEPTH GAUGE |
| Product Code | EIL |
| Date Received | 2016-11-17 |
| Model Number | N/A |
| Catalog Number | SP-1248 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-11-17 |