MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-12-12 for SEE H10 N/A manufactured by Zimmer Biomet, Inc..
[173647598]
(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. The following sections could not be completed as the part/lot information could be any of the following: brand name: lp non lock, catalog number: 131227210 , or brand name: lp non lock, catalog number: 131227211, or brand name: lp non lock , catalog number: 131227212, or brand name: lp non lock, catalog number: 131227213, or brand name: lp non lock, catalog number: 131227214, or brand name: lp non lock, catalog number: 131227220, or brand name: lp non lock, catalog number: 131227222, or brand name: lock screw square, catalog number: 131227114, or brand name: lock screw square, catalog number: 131227115, or brand name: lock screw square, catalog number: 131227116, or brand name: lock screw square, catalog number: 131227118. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05268, 0001822565 - 2019 - 05270, 0001822565 - 2019 - 05271, 0001822565 - 2019 - 05272, 0001822565 - 2019 - 05273, 0001822565 - 2019 - 05274, 0001822565 - 2019 - 05275, 0001822565 - 2019 - 05276, 0001822565 - 2019 - 05277, 0001822565 - 2019 - 05278, 0001822565 - 2019 - 05279.
Patient Sequence No: 1, Text Type: N, H10
[173647599]
It was reported that the patient was undergoing a wrist fixation procedure. After implantation of the plate and screws, and running the wrist through range of motion, the plate/screw construct fell apart. Due to this, all reduction was lost, although some of the screws did stay in loosely. The surgeon wanted to start over with the same plate, but with different screws. Further, there were 3 screws that would not initially seat properly. The surgeon completed the procedure with the same plate and new screws. 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 | 0001822565-2019-05269 |
| MDR Report Key | 9459147 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-12-12 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2019-11-21 |
| Date Added to Maude | 2019-12-12 |
| 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 | SEE H10 |
| Generic Name | SCREW, FIXATION |
| Product Code | LXT |
| Date Received | 2019-12-12 |
| Model Number | N/A |
| Catalog Number | SEE H10 |
| Lot Number | NI |
| 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 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-12 |