MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for UNKNOWN DRILL N/A manufactured by Zimmer Biomet, Inc..
[128070233]
(b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Review of device history records found these units were released to distribution with no deviations or anomalies. Dhr review cannot be performed for the drill without product identification. Root cause could not be determined. 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. Medical devices: part # 912068, juggerknot 1. 4 mm short w/ needles, lot # 433510. Event occurred in (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08742.
Patient Sequence No: 1, Text Type: N, H10
[128070234]
It was reported that after drilling into the patient, the surgeon was unable to insert the juggerknot soft anchor due to the hole being too small. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-10842 |
| MDR Report Key | 8091917 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-11-20 |
| 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 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN DRILL |
| Generic Name | INSTRUMENT, SURGICAL |
| Product Code | HAO |
| Date Received | 2018-11-20 |
| Model Number | N/A |
| Catalog Number | UNKNOWN DRILL |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-11-20 |