MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-18 for ADULT CRANIOTOME CRANI-A-G1 manufactured by Depuy Synthes Products Llc.
[184652590]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The actual device was returned for evaluation. Reliability engineering evaluated the craniotome device and the reported condition that the device was broken was confirmed. An assessment was performed and it was observed that the neuro-tip leg of the device was bent. It was determined that the bent neuro-tip leg was due to excessive lateral force being placed on the device causing the neuro-tip leg to bend (90 degrees). The assignable root cause of this condition was determined to be traced to user error. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184652591]
It was reported from (b)(6) that the craniotome device was broken. During in house engineering evaluation it was observed that the neuro-tip leg of the device was bent. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was not reported, however, it was reported that the event occurred in 2020. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2020-00508 |
| MDR Report Key | 9849279 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2014-08-19 |
| Date Added to Maude | 2020-03-18 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Street | 4500 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 | ADULT CRANIOTOME |
| Generic Name | MOTOR, DRILL, ELECTRIC - CRANIOTOME |
| Product Code | HBC |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-09 |
| Catalog Number | CRANI-A-G1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |