MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-02-22 for ADAPT ?2.8 F/LCP PAED-HIP PL3.5/5.0 03.108.040 manufactured by Synthes Gmbh.
[18623750]
Device report from (b)(6) reports an event in (b)(6) as follows: the shaft of the k-wire adaptor used in procedures previously, was worn and exhibited grooves. It was reported the adaptor was used approximately 10 times. This is 1 of 1 report.
Patient Sequence No: 1, Text Type: D, B5
[18761109]
Device was used for treatment, not diagnosis. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn. Manufacturing documents were reviewed and no complaint related issues were found. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[21909190]
Device used for treatment and not diagnosis. The adapter was analyzed for conformance to print specifications as well as the device history record was researched; no abnormal findings were identified. Manufacturing and inspection records indicated no problems with the lot in question. Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances. We found that around on the adapter shaft are badly damaged and show clearly visible stress marks. The excessive damage to the shaft indicates that the receptacles of the adapter was on the whole shaft and was not at the designated three interface coupling end. No product fault could be detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-00611 |
| MDR Report Key | 2974840 |
| Report Source | 01,07 |
| Date Received | 2013-02-22 |
| Date of Report | 2013-01-14 |
| Date of Event | 2013-01-14 |
| Date Mfgr Received | 2013-03-22 |
| Device Manufacturer Date | 2011-02-02 |
| Date Added to Maude | 2013-05-02 |
| 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 | SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADAPT ?2.8 F/LCP PAED-HIP PL3.5/5.0 |
| Generic Name | ADAPTER |
| Product Code | HXS |
| Date Received | 2013-02-22 |
| Returned To Mfg | 2013-02-12 |
| Catalog Number | 03.108.040 |
| Lot Number | 2598684 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-22 |