MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-03 for MED HOWMEDICA BONE PLUG 1PK 6215-5-011 manufactured by Stryker Orthopaedics-mahwah.
[113205977]
When completed, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[113205978]
Two separate bone plugs were opened for surgery and deemed unsterile due to seal on packaging. Update 12/jun/2018: spoke to rep. The seal on the outer blister was not adhered to the outer blister all the way around and there were 'gaps' allowing air to pass in and out. The seal on the inner blister was also not adhered to the inner blister all the way around with the same 'gaps'. This happened with 2 devices with 2 different lots. The outer boxes were discarded before the rep could retrieve them. Primary tka procedure. Rep was present in the operating room and witnessed the event. Additional devices were immediately available in the operating room and there was no surgical delay - the surgeon was not even aware of the event until after the procedure was complete.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2018-02030 |
| MDR Report Key | 7658868 |
| Date Received | 2018-07-03 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2018-07-03 |
| 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 | MR. JOANN LAVATELLI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MED HOWMEDICA BONE PLUG 1PK |
| Generic Name | CEMENT OBTURATOR |
| Product Code | LZN |
| Date Received | 2018-07-03 |
| Returned To Mfg | 2018-06-14 |
| Catalog Number | 6215-5-011 |
| Lot Number | CPPUE07BC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-03 |