MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-12 for BMP SLEEVE GRIP CRIMPER N/A 498003 manufactured by Zimmer Biomet, Inc..
[100006443]
(b)(4) concomitant medical products: 498003, bmp sleeve grip crimper, mmx1772. The 498003, bmp sleeve grip crimper, mmx1877. (b)(6). 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00754, 0001825034-2018-00755.
Patient Sequence No: 1, Text Type: N, H10
[100006444]
It was reported that the instrument was found broken. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-00753 |
| MDR Report Key | 7262816 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-12 |
| Date of Report | 2018-07-05 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2016-12-29 |
| Date Added to Maude | 2018-02-12 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | BMP SLEEVE GRIP CRIMPER |
| Generic Name | CRIMPER, PIN |
| Product Code | HXQ |
| Date Received | 2018-02-12 |
| Returned To Mfg | 2018-03-01 |
| Model Number | N/A |
| Catalog Number | 498003 |
| Lot Number | 637670 |
| ID Number | (01) 0 0880304 00960 8 |
| Operator | PHYSICIAN |
| 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 | 2018-02-12 |