MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for 10CC HYDROSET INJECTABLE CEMENT 79-43910 manufactured by Stryker Leibinger Freiburg.
[43033270]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device was discarded at the facility; however, pictures were supplied to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[43033271]
It was reported that prior to surgery, the surgeon proceeded to open the hydroset packaging and noticed that there was a hair in half of the sterile portion and half outside the sterile packaging. The company representative was not available for the case.
Patient Sequence No: 1, Text Type: D, B5
[68136879]
A confirmation of the reported event was not applicable because neither the complained device nor a photo evidence was provided for investigation. The investigation conducted is based on the reviews of the batch manufacturing records (bmr). The device is manufactured by (b)(4). So the complaint information was forwarded to the manufacturing facility. The reviews of the bmr were completed and no discrepancies were recorded. It has been confirmed that the product and its components (liquid and powder components) were manufactured per validated conditions. Further possible root causes for the potentially identified hazard (particle/debris) are according to the risk management file: excessive forces (e. G. Moving, positioning, holding). Wrongly assembled instruments/ implants. Occurring during shipping/ transportation. Based on the evaluation no indications for any design, material or manufacturing related problems were found in this investigation. Device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[68136900]
It was reported that prior to surgery, the surgeon proceeded to open the hydroset packaging and noticed that there was a hair in half of the sterile portion and half outside the sterile packaging. The company representative was not available for the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2016-00070 |
| MDR Report Key | 5571271 |
| Date Received | 2016-04-12 |
| Date of Report | 2017-02-17 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2016-04-12 |
| 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. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 10CC HYDROSET INJECTABLE CEMENT |
| Generic Name | IMPLANT |
| Product Code | GXP |
| Date Received | 2016-04-12 |
| Catalog Number | 79-43910 |
| Lot Number | T955HIC02008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-12 |