MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-04-16 for TOGGLELOC/WASHERLOC DISP KIT N/A 909846 manufactured by Zimmer Biomet, Inc..
[105566650]
(b)(4). Customer has indicated that the product will not be returned because product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location is unknown.
Patient Sequence No: 1, Text Type: N, H10
[105566651]
It was reported a patient underwent a procedure to remove a piece of guide wire from the knee joint. Patient had undergone an arthroscopic procedure seven days prior. The guide wire was found via x-ray.
Patient Sequence No: 1, Text Type: D, B5
[118005307]
(b)(4). This follow-up report is being submitted to relay additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2018-02596 |
| MDR Report Key | 7433196 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-04-16 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2017-12-06 |
| Date Added to Maude | 2018-04-16 |
| 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 | TOGGLELOC/WASHERLOC DISP KIT |
| Generic Name | KIT, SURGICAL INSTRUMENT |
| Product Code | KDD |
| Date Received | 2018-04-16 |
| Model Number | N/A |
| Catalog Number | 909846 |
| Lot Number | 215190 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-16 |