MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.) N/A 00392500200 manufactured by Zimmer Biomet, Inc..
[130320665]
(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. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[130320666]
It was reported that during the procedure, one of the teeth at the tip of the rod cutter fractured off. No adverse events have been reported as a result of the malfunction. Additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-06912 |
| MDR Report Key | 8160939 |
| Date Received | 2018-12-13 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-11-19 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2018-12-13 |
| 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 | 0 |
| Brand Name | SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.) |
| Generic Name | TRAUMA, INSTRUMENT |
| Product Code | HXZ |
| Date Received | 2018-12-13 |
| Returned To Mfg | 2019-02-18 |
| Model Number | N/A |
| Catalog Number | 00392500200 |
| Lot Number | 63696619 |
| 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 | 2018-12-13 |