MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-04-01 for CORE DECOMPRESSION DISP HIP N/A 800-0541 manufactured by Biomet Orthopedics.
[41651078]
Device code - fmf. Device info - quantity 2. Device availability - the device is reportedly available for return, but has not yet been received. This device has not yet returned; however, an evaluation was completed on another device of the same lot. Conclusion: device out of specification in a manner that relates to the event. Evaluation of another device from the same lot revealed evidence of product non-conformance. Corrective and preventive actions have been initiated to address the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[41651079]
It was reported that patient underwent a core decompression procedure for avascular necrosis on (b)(6) 2016. During the procedure, the sharp and blunt trocars were missing in the packaging. Another core decompression kit was opened, but was also missing trocars. The procedure was completed with the use of a kirschner wire, resulting in a delay of 55 minutes.
Patient Sequence No: 1, Text Type: D, B5
[43296309]
This follow-up report is being filed to relay corrected information. Device availability - the device is reported to be available for return to manufacturer; however, it has not been received by biomet orthopedics to date. In the event that the device is received, a follow up report will be sent to the fda. An evaluation of the device will not be necessary, as the device problem is already known. Decision was made to recall based on an investigation which identified that trocar and plunger assemblies were missing from the package containing the perfuse decompression instrument. This could result in a delay to a surgical procedure while an alternative instrument is located.
Patient Sequence No: 1, Text Type: N, H10
[45287372]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-01103 |
| MDR Report Key | 5541109 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-04-01 |
| Date of Report | 2016-04-13 |
| Date of Event | 2016-03-16 |
| Date Mfgr Received | 2016-04-13 |
| Device Manufacturer Date | 2015-08-19 |
| Date Added to Maude | 2016-04-01 |
| 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. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1825034-4/7/2016-006R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORE DECOMPRESSION DISP HIP |
| Generic Name | SYRINGE, PISTON |
| Product Code | NKN |
| Date Received | 2016-04-01 |
| Returned To Mfg | 2016-04-13 |
| Model Number | N/A |
| Catalog Number | 800-0541 |
| Lot Number | 100650 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-01 |