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 DISK DRILL N/A 423872 manufactured by Zimmer Biomet, Inc..
[87872718]
(b)(4). Multiple mdr reports were submitted for this event. Please see reports: 0001825034 - 2017 - 07209. 0001825034 - 2017 - 07210. 0001825034 - 2017 - 07211. 0001825034 - 2017 - 07212. 0001825034 - 2017 - 07213. (b)(4). Concomitant products: 423924 ultra-drive 9. 5mm helical tip, lot 764230. 423924 ultra-drive 9. 5mm helical tip, lot 764230. 423838 ultra drive 120mm tip extender, lot 427370. 423838 ultra drive 120mm tip, lot 367150. 423872 ultra-drive 9. 5mm 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.
Patient Sequence No: 1, Text Type: N, H10
[87872719]
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
[120870048]
(b)(4). This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was not confirmed. Visual inspection could not confirm the drill to be fractured. Only minor surface scuffing and scratching was observed on the shaft and tightening notch of the bit. Root cause was unable to be determined. Dhr was reviewed and no discrepancies relevant to the reported event were found. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-07213 |
| MDR Report Key | 6883752 |
| 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 | 2016-08-26 |
| 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 DISK DRILL |
| Generic Name | INSTRUMENT, HIP |
| Product Code | JXE |
| Date Received | 2017-09-21 |
| Returned To Mfg | 2017-11-06 |
| Model Number | N/A |
| Catalog Number | 423872 |
| Lot Number | 055650 |
| 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 |