MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-10 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Synthes Tuttlingen.
[64288070]
Device used in a veterinary case - no patient information will be reported. Date of event is unknown. Implant and explant date: device is an instrument and is not implanted / explanted. Device history records review was completed for part# 399. 36, lot# a7na23. Manufacturing date: week 23 in 2004. The dhr is no longer available due to the age of the instrument (over 12 years old). The exact date of manufacture is unknown. The device was received and the product evaluation is in progress. No conclusion can be drawn. 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
[64288071]
This report is for a veterinary case. There was no human patient involvement. It was reported on (b)(6) 2016, that the handle of a periosteal elevator curved blade shattered. Reportedly, on an unknown date (about one week ago) after a cranial cruciate repair on a veterinarian subject was completed, while the doctor was collecting the instruments he picked up the elevator and placed it in a plastic container and the handle shattered. The malfunction occurred away from the operative field. The fragment pieces were easily retrieved. There was no harm reported to the veterinarian subject. The doctor was unsure where he purchased the synthes instrument but reported he had it since approximately ten (10) years. This report is for one (1) periosteal elevator 6mm curved blade-round edge. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[67556090]
Additional narrative: product development investigation was performed. The catalog #399. 36, lot number a7na23 periosteal elevator was returned and reported that the handle shattered. This complaint condition was likely caused by over twelve years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency. A visual inspection, functional test, and drawing review were performed as part of this investigation. This complaint is confirmed. The cat #399. 36 periosteal elevator is an instrument routinely used in the small fragment locking compression plate (lcp) system. The device was returned and reported that the handle shattered. This condition is confirmed; the phenolic handle of the device was received in two pieces having broken in a? Z? Shape at the end of the metal shaft component. It is likely that over twelve years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition. The device was manufactured in 6/2004 and is over twelve years old. The balance of the returned device is in fairly worn condition with several markings and some discoloration. Drawing number was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. The condition of the returned device does agree with the complaint description. Whether the complaint condition for this device can be replicated is not applicable for this condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. 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
| Report Number | 9680938-2017-10001 |
| MDR Report Key | 6236479 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-10 |
| Date of Report | 2016-12-16 |
| Date Mfgr Received | 2017-01-31 |
| Date Added to Maude | 2017-01-10 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2017-01-10 |
| Returned To Mfg | 2016-12-22 |
| Catalog Number | 399.36 |
| Lot Number | A7NA23 |
| 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 TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-10 |