MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-04-30 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Synthes Monument.
[5770208]
It was reported that the wooden handle of the periosteal elevator 6mm curved blade-round edge is broken off. It was discovered in the sterile processing department; there was not patient involvement. During evaluation of the device, it was noted that the majority of the handle material has separated away from the shaft of the device, and the remaining portion is cracked about the pin. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13254401]
Device is an instrument and is not implanted/explanted. Service history review: lot a7ka50/4367923: no service history review can be performed as this is a lot controlled item. The service history evaluation is unconfirmed. The customer reported the handle was broken. The repair technician reported the blade was burred. Worn out parts is the reason for repair. The item is not repairable. The cause of the issue is unknown. This item was forwarded to the complaint handling unit. The evaluation was confirmed. A product investigation was completed: one periosteal elevator 6mm (part 399. 36, manufacturer lot a7ka50, synthes lot 4367923, manufactured january 2002) was returned. Upon receipt of this device it was seen that a majority of the handle material has separated away from the shaft of the device, and the remaining portion is cracked about the pin. This complaint is confirmed. The drawings for this device were reviewed and no dimensional non-conformances were found for this device. Given the age of this instrument, the material of the handle, and the evident signs of use, this complaint can likely be attributed to regular use over time coupled with repeated sterilization cycles. The design of this device is adequate for its intended use. 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 | 1719045-2015-10260 |
| MDR Report Key | 4740596 |
| Report Source | 07 |
| Date Received | 2015-04-30 |
| Date of Report | 2015-04-22 |
| Date Mfgr Received | 2015-04-22 |
| Device Manufacturer Date | 2002-01-16 |
| Date Added to Maude | 2015-06-02 |
| 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 | 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 MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| 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 | 2015-04-30 |
| Returned To Mfg | 2015-01-23 |
| Catalog Number | 399.36 |
| Lot Number | 4367923 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-30 |