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 2020-03-31 for 45 DEG ANGLE DRILL 2366-83-000 236683000 manufactured by Depuy Orthopaedics Inc Us.
[186847660]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[186847661]
The primary surgery was performed on (b)(6) 2020 via tha. During the surgery, after the reaming of acetabular roof, first drilling and inserted a screw, when the surgeon tried the second drilling with the drill (p/n: 236683000), the drill bit and the shaft of the drill rotated together, not only the drill bit turned, and the surgeon could not drill. The surgery was completed without any surgical delay. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09762 |
| MDR Report Key | 9905428 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-18 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2008-02-15 |
| Date Added to Maude | 2020-03-31 |
| 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 | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 45 DEG ANGLE DRILL |
| Generic Name | DRILLS (BITS, SLEEVES, GUIDES) : DRILLS |
| Product Code | HTW |
| Date Received | 2020-03-31 |
| Model Number | 2366-83-000 |
| Catalog Number | 236683000 |
| Lot Number | A0208 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |