MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for WASHER FOR SCREWS: ?4.5/6.5/8.0MM 390016S manufactured by Stryker Gmbh.
[92217580]
The reported event that washer for screws:? 4. 5/6. 5/8. 0mm was alleged of issue s-41 (poor fixation) could not be confirmed since the device was not returned for evaluation and no other evidences were provided. A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation. A review of the labeling did not indicate any abnormalities. As clearly stated in ifu, ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system. Based on investigation, the root cause could be attributed to a user related issue. The failure could have been caused due to wrong selection of screw or washer. However, please bear in mind that more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event. A review of the device history record for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. No indications of material, manufacturing or design related problems were found during the investigation. If the device is returned or if any additional information is provided, the investigation will be reassessed. Product discarded.
Patient Sequence No: 1, Text Type: N, H10
[92217581]
The customer reported that the surgeon, was using a 6. 5 asnos screw and the head of the screw went straight through the washer. The case was completed successfully, although the screw was left without a washer. There was a few minutes delay while the screw was removed from the patient - this was an asnis 6. 5 hip screw done percutaneously so difficult to retrieve from small incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2017-00642 |
| MDR Report Key | 7015146 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-10-15 |
| Date Mfgr Received | 2017-10-16 |
| Device Manufacturer Date | 2017-04-04 |
| Date Added to Maude | 2017-11-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WASHER FOR SCREWS: ?4.5/6.5/8.0MM |
| Generic Name | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2017-11-09 |
| Model Number | 390016S |
| Catalog Number | 390016S |
| Lot Number | L08060 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-09 |