MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-13 for 2.5 MM FEMALE HEX SCREW 25 MM LENGTH N/A 42509902525 manufactured by Zimmer Biomet, Inc..
[127074578]
(b)(4). (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. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[127074579]
It was reported that during a total knee arthroplasty, when the nurse peeled the outer tyvek, the inner sterile tyvek was also peeled, because it already had adhered to the outer tyvek. The products within the inner sterile tray flew out and fell on the floor. Other pins were used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-06405 |
| MDR Report Key | 8066154 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2018-08-31 |
| Date Added to Maude | 2018-11-13 |
| 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 | 3 |
| Brand Name | 2.5 MM FEMALE HEX SCREW 25 MM LENGTH |
| Generic Name | INSTRUMENT, KNEE |
| Product Code | HWD |
| Date Received | 2018-11-13 |
| Returned To Mfg | 2018-12-05 |
| Model Number | N/A |
| Catalog Number | 42509902525 |
| Lot Number | 64153303 |
| 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 | 2018-11-13 |