MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-07-24 for BENDING IRON FOR 3.5MM & 4.5MM RECONSTRUCTION PLATES 329.080 manufactured by Umkirch.
[4832400]
There was patient involvement since it occurred during surgery, but no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[12354579]
Additional narrative: a manufacturing evaluation was completed: the investigation has confirmed that one pin broke off from the bending iron. Investigation of documentation for production and material give evidence that the instrument was produced under specifications in 2005. Failure in material or production could not be detected. It is not possible without any further knowledge to detect the exact cause of the broken pin. No product fault could be detected. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[20454024]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the pin at the bending iron broken during surgery. There were no patient involved, no prolongation of the surgery. This report is 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20566075]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. No non conformance reports were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003862213-2014-10037 |
| MDR Report Key | 3956415 |
| Report Source | 01,05,07 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-06-30 |
| Date Mfgr Received | 2014-07-22 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2014-08-04 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | UMKIRCH |
| Manufacturer Street | IM KIRCHENHURSTLE 4 |
| Manufacturer City | UMKIRCH B. FREIBURG D-79224 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79224 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDING IRON FOR 3.5MM & 4.5MM RECONSTRUCTION PLATES |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2014-07-24 |
| Returned To Mfg | 2014-07-22 |
| Catalog Number | 329.080 |
| Lot Number | 6010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UMKIRCH |
| Manufacturer Address | IM KIRCHENHURSTLE 4 UMKIRCH B. FREIBURG D-79224 GM D-79224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-24 |