MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-09-21 for ULTRA-DRIVE 9.5MM HELICAL TIP N/A 423924 manufactured by Zimmer Biomet, Inc..
[87734272]
(b)(4). Mfr reports: 0001825034-2017-07210, 0001825034-2017-07211, 0001825034-2017-07212, 0001825034-2017-07213. (b)(4). Concommitant medical products - 423924 ultra-drive 9. 5 mm helical tip, lot 764230. 423924 ultra-drive 9. 5 mm helical tip, lot 764230. 423838 ultra drive 120 mm tip extender, lot 427370. 423838 ultra drive 120 mm tip, lot 367150. 423872 ultra-drive 9. 5 mm disk drill, lot 055650. 423936 ultra-drive iii handpiece, lot 42695. 423936 ultra-drive iii handpiece, lot 42698. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[87734273]
It was reported the ultra-drive did not perform as intended. Subsequently, the disposable instruments fractured while attempting to remove the cement plug. A femoral osteotomy was ultimately performed to remove the cement plug. Surgery was delayed 31-60 minutes. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07209 |
| MDR Report Key | 6883412 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-09-21 |
| Date of Report | 2018-09-19 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2013-11-04 |
| Date Added to Maude | 2017-09-21 |
| 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 9.5MM HELICAL TIP |
| Generic Name | INSTRUMENT, HIP |
| Product Code | JXE |
| Date Received | 2017-09-21 |
| Returned To Mfg | 2017-11-06 |
| Model Number | N/A |
| Catalog Number | 423924 |
| Lot Number | 764230 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2017-09-21 |