MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-12-11 for ULTRA-DRIVE DISK DRILL N/A 423873 manufactured by Zimmer Biomet, Inc..
[130049222]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 423871 ultra drive disk drill, 186730. 423838 ultra drive tip extender, 688070. 423836 ultra drive tip extender, 434510. 423872 ultra drive disk drill, 112350. 423874 ultra drive disk drill, 716550. 423836 ultra drive tip extender, 123460.
Patient Sequence No: 1, Text Type: N, H10
[130049223]
It was reported that during a hip arthroplasty the instrument broke. Attempts have been made and no further information has been provided. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-11213 |
| MDR Report Key | 8152576 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-12-11 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-11-10 |
| Date Mfgr Received | 2019-02-04 |
| Device Manufacturer Date | 2018-07-28 |
| Date Added to Maude | 2018-12-11 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-DRIVE DISK DRILL |
| Generic Name | INSTRUMENT, HIP |
| Product Code | JDX |
| Date Received | 2018-12-11 |
| Model Number | N/A |
| Catalog Number | 423873 |
| Lot Number | 078290 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-11 |