MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-09 for 3.5 MM / 2.7 MM PLATE REDUCTION INSTRUMENT 00236001101 manufactured by Zimmer Biomet, Inc..
[158665236]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[158665237]
It was reported that the instrument fractured during the procedure. Attempts have been made, and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2019-03818 |
| MDR Report Key | 8974041 |
| Date Received | 2019-09-09 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-08-16 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2017-11-07 |
| Date Added to Maude | 2019-09-09 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5 MM / 2.7 MM PLATE REDUCTION INSTRUMENT |
| Generic Name | TRAUMA, INSTRUMENT |
| Product Code | HWN |
| Date Received | 2019-09-09 |
| Returned To Mfg | 2019-10-17 |
| Catalog Number | 00236001101 |
| Lot Number | 63855643 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-09-09 |