MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for UNIVERSAL BENDING IRON 329.031 manufactured by Synthes Brandywine.
[41764483]
Patient information not available for reporting, device is an instrument and is not implanted/explanted. Service and repair evaluation - the customer reported the handle broke. The repair technician reported handle cracked/broken as the reason for repair. The item is not repairable per the inspection sheet. The cause of the issue is unknown. The item will be forwarded to customer quality. The evaluation was confirmed. 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
[41764484]
It was reported by service and repair that a handle broke during a right mandible fracture surgery. Patient is doing well and there was no delay in surgery. This complaint involves 1 device.
Patient Sequence No: 1, Text Type: D, B5
[42799355]
Device was used for treatment, not diagnosis. A service history record review was attempted for the subject device; however, it could not be completed because the device is a lot/batch controlled item. A device history record (dhr) review was performed for the subject device lot. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. The subject device is currently in the evaluation process at synthes customer quality the results of this evaluation are pending completion. Manufacturing location was corrected based on dhr results. 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
[44587101]
Product investigation summary: the returned device was sent for service and repair where the complaint condition was able to be confirmed as the handle was found to be broken. The device was deemed unrepairable and forwarded to customer quality for investigation. The distal most quarter of the handle was split longitudinally and broken off of the remaining handle. The device was checked for functionality and was found to operate as intended. The returned condition is consistent with extensive wear and repeated sterilization of the device over an extended lifetime. The handle material is phenolic le grade, which is susceptible to becoming brittle after being subjected to years of thermal cycling, which routinely occurs during sterilization cycles. The device is 10+ years old; therefore, the device age is likely a contributing factor. The universal bending iron is not noted in a system technique guide; however, it is covered on a product information sheet. The bending iron is designed to bend 2. 4mm microvascular, universal fracture, locking reconstruction, and thorp plates in three dimensions: in-plane, out-of-plane and torsional. The relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision): top-level and handle. The design, materials, and finishing processes were found to be appropriate for the intended use of these devices. No definitive root cause was able to be determined; the returned condition is consistent with extensive wear and repeated sterilization of the device over an extended lifetime. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. Device 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
| Report Number | 1719045-2016-10277 |
| MDR Report Key | 5536429 |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-16 |
| Date Mfgr Received | 2016-05-04 |
| Device Manufacturer Date | 2006-01-30 |
| Date Added to Maude | 2016-03-30 |
| 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 | 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 | SYNTHES BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL BENDING IRON |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2016-03-30 |
| Returned To Mfg | 2016-03-22 |
| Catalog Number | 329.031 |
| Lot Number | 5161556 |
| ID Number | (01)10887587039169(10)5161556 |
| 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 BRANDYWINE |
| Manufacturer Address | 1303 GOSHEN PARKWAY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-30 |