MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-04-10 for JGRKNT 1.0MM MINI 3-0 NDLS N/A 912082 manufactured by Zimmer Biomet, Inc..
[141481304]
(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. Unique identifier (udi) #: (b)(4). Event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141481305]
It was reported that during a procedure, the tip of the inserter fractured when the surgeon was attempted to insert the implant into the patient's burr hole. The fractured piece was able to be recovered from the patient's body. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01636 |
| MDR Report Key | 8500056 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-04-10 |
| Date of Report | 2019-07-01 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-06-26 |
| Device Manufacturer Date | 2013-06-02 |
| Date Added to Maude | 2019-04-10 |
| 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 | JGRKNT 1.0MM MINI 3-0 NDLS |
| Generic Name | FASTENER, FIXATION |
| Product Code | DZL |
| Date Received | 2019-04-10 |
| Returned To Mfg | 2019-04-23 |
| Model Number | N/A |
| Catalog Number | 912082 |
| Lot Number | 763040 |
| 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 | 1. Required No Informationntervention | 2019-04-10 |