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 2017-12-07 for TOGGLELOC/WASHERLOC DISP KIT N/A 909846 manufactured by Zimmer Biomet, Inc..
[94128187]
Cmp-(b)(4). Device product code - kdd. 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
[94128188]
It was reported that during an acl reconstruction, the drill bit fractured inside the patient, causing the surgeon to go in and remove the fractured piece. No further patient consequences were reported. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[114203789]
(b)(4). This follow-up report is being submitted to relay additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-10775 |
| MDR Report Key | 7095173 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-12-07 |
| Date of Report | 2018-04-26 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2017-06-21 |
| Date Added to Maude | 2017-12-07 |
| 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 | 2017-12-07 |
| Returned To Mfg | 2017-11-28 |
| Model Number | N/A |
| Catalog Number | 909846 |
| Lot Number | 969580 |
| ID Number | (01) 00880304463905 (17) 22062 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2017-12-07 |