MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for 4.4MM DRILL SLEEVE N/A 281012012 manufactured by Zimmer Biomet, Inc..
[95745988]
Zimmer biomet complaint: (b)(4). Complaint sample was evaluated and the reported event was not confirmed. Based on dhrs, the product was made to print and correct materials. Product left conforming to print as there was no evidence that states otherwise. Product likely failed due to misuse, by instrument being put through excessive force or torsional/bending overload, and/or not inspected for wear and disfigurement and prior to surgery or rekitting, which may have prevented the use of the instrument and its failure. The mention of debris, rust, corrosion and contaminates in email correspondence was not identified on product returned. This was not a supplier issue. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Investigation results concluded that the reported event was due to customer error: instrument damaged or worn beyond useful life and improper torque. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device. 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
[95745989]
It was reported that the sheaths and trochars are described as "damaged" at tip and at entry points. The entry reamer is also chipped. There is also reports of contaminates/rust and debris. This was discovered as the trays were opened and did not occur during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-11085 |
| MDR Report Key | 7112973 |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-12 |
| Date of Event | 2014-05-06 |
| Date Mfgr Received | 2014-05-05 |
| Device Manufacturer Date | 2008-08-05 |
| Date Added to Maude | 2017-12-13 |
| 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 | 0 |
| Brand Name | 4.4MM DRILL SLEEVE |
| Generic Name | INSTRUMENT, MANUAL |
| Product Code | HBD |
| Date Received | 2017-12-13 |
| Returned To Mfg | 2014-08-27 |
| Model Number | N/A |
| Catalog Number | 281012012 |
| Lot Number | C131N4 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-12-13 |