MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for RUSH AWL 2.5MM DIAMETER REAMER 31810616700 manufactured by Zimmer, Inc..
[63312870]
The reamer was returned for evaluation. As returned, the awl is bent and has fractured at the base of the handle. Review of receiving inspection report for the device indicates the devices were manufactured to specifications. Inspection documentation shows all devices that were inspected met specifications. Wear & tear is seen that indicates successful use during a potential field age of approximately 10 years 10 months. Dimensional measurements are conforming to print specifications. The instrument was manufactured on september 22, 2005. This device is used for treatment. Initial product history search conducted on september 28th 2016 revealed no additional complaints against the related part and lot combination. Wear and tear has been determined to be the root cause for the instrument fracture.
Patient Sequence No: 1, Text Type: N, H10
[63312871]
It is reported that the device was found to be fractured during kit inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-04753 |
| MDR Report Key | 6190321 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-07-28 |
| Date Mfgr Received | 2016-11-22 |
| Device Manufacturer Date | 2005-09-22 |
| Date Added to Maude | 2016-12-20 |
| 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, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RUSH AWL 2.5MM DIAMETER REAMER |
| Generic Name | ELBOW INSTRUMENT |
| Product Code | HWJ |
| Date Received | 2016-12-20 |
| Returned To Mfg | 2016-08-12 |
| Model Number | NA |
| Catalog Number | 31810616700 |
| Lot Number | 60351086 |
| ID Number | NA |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-20 |