MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-05-24 for INSERTER-LARGE SFW673R manufactured by Synthes (usa).
[3453640]
It was reported that pivot screw broke. No further information was provided. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10741502]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. The device listed in this report is used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Device is not distributed in the united states, but is similar to device marketed in the usa. A review of the dhr indicates there were no anomalies which could have caused or contributed to this complaint. The manufacturing records were reviewed and no complaint related issues were found. The suppliers certifications indicate the correct material was used and correct hardness values were obtained. All records indicate the product was manufactured to specifications. The investigation carried out revealed that that the screw of the guide arm has broken off. We suspect that the screw broke off due to an excessive mechanical load at the top of the guide bar. Due to other messages from the market, a capa determination request has been initiated in order to find the failure cause and propose corrective and preventive actions, including a design change. The design was amplified and the screw area was reinforced. This design change was implemented after the release of the implicated device. This instrument was manufactured in 2005 and still reflects the old version.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-02871 |
| MDR Report Key | 3130933 |
| Report Source | 01,07 |
| Date Received | 2013-05-24 |
| Date of Report | 2011-06-17 |
| Date Mfgr Received | 2011-06-17 |
| Device Manufacturer Date | 2005-10-13 |
| Date Added to Maude | 2013-08-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | T. MCCARRON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSERTER-LARGE |
| Product Code | MCV |
| Date Received | 2013-05-24 |
| Catalog Number | SFW673R |
| Lot Number | A7OA40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-24 |