MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-20 for EXACT REV FP RASP 10 N/A SSI005610 manufactured by Zimmer Biomet, Inc..
[188862394]
(b)(4). Customer has indicated that he product will not be returned to zimmer biomet for the investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01217, 0001825034-2020-01218, 0001825034-2020-01220, 0001825034-2020-01222, 0001825034-2020-01223.
Patient Sequence No: 1, Text Type: N, H10
[188862395]
It was reported that patient rasp instruments were found to have fractured on the medial side. It is unknown how and/or when the fractures occurred and no known harm or injury to a patient. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01221 |
| MDR Report Key | 9859996 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-20 |
| 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 | EXACT REV FP RASP 10 |
| Generic Name | HIP INSTRUMENT |
| Product Code | HTQ |
| Date Received | 2020-03-20 |
| Model Number | N/A |
| Catalog Number | SSI005610 |
| Lot Number | 97018265 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-20 |