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 2018-08-14 for 2.5 MM FEMALE HEX SCREW 25 MM LENGTH N/A 42509902525 manufactured by Zimmer Biomet, Inc..
[117148568]
Zimmer biomet complaint number (b)(4). Foreign: (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.
Patient Sequence No: 1, Text Type: N, H10
[117148569]
It was reported that during the inspection, it was noted that a bug was found in the package. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-04376 |
| MDR Report Key | 7782915 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2012-09-14 |
| Date Added to Maude | 2018-08-14 |
| 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 | 2.5 MM FEMALE HEX SCREW 25 MM LENGTH |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | HWD |
| Date Received | 2018-08-14 |
| Returned To Mfg | 2018-09-13 |
| Model Number | N/A |
| Catalog Number | 42509902525 |
| Lot Number | 62175476 |
| 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 | 2018-08-14 |