MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-05 for PERIOSTEAL ELEVATOR 20MM STRAIGHT BLADE-ROUND EDGE 399.38 manufactured by Synthes Tuttlingen.
[48752596]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received. (b)(6). A device history record review was attempted for the subject device lot 4615664, supplier lot number a7ma21. The subject device lot was manufactured on week 21, 2003 (exact date is unknown). The device history records for this instrument lot are no longer available since the age of the device is greater than 13 years. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[48752597]
(b)(6) reported the following event: it was reported that the handle of the periosteal elevator broke into two pieces during an unspecified initial surgical procedure on (b)(6) 2016. There was no reported surgical delay or patient harm. This report is 1 of 1 for com- (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[53684520]
A product investigation was completed: the complaint condition is confirmed. A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment, where applicable, was found to adequately address the complaint condition. Per the technique guide, the returned instrument is a common instrument used for pelvic implants and instruments. It is designed to simplify the dissection and atraumatic exposure of the bone. It serves to free the bone source from soft tissues in order to prepare the fractures surfaces for definitive fixation. The returned instrument was examined and the complaint condition was able to be confirmed as the device handle was found to have fractured along the cross-pin hole. The balance of the device shows surface wear and is in functional condition. A review of the current design drawing and available history for the instrument was performed. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned parts were determined to be suitable for their intended use when employed and maintained as recommended. The device history record could not be done for the instrument because is no longer available due to the age of the instrument (over 13 years old). No definitive root cause was able to be determined however the failure mode is consistent with wear/tear of the instruments? Phenolic handles which are susceptible to becoming brittle after being subjected to years of thermal cycling which routinely occurs during sterilization cycles. 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 | 9680938-2016-10095 |
| MDR Report Key | 5769195 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-13 |
| Date of Event | 2016-06-13 |
| Date Mfgr Received | 2016-08-02 |
| Date Added to Maude | 2016-07-05 |
| 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 | TERRY CALLAHAN |
| 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 20MM STRAIGHT BLADE-ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2016-07-05 |
| Returned To Mfg | 2016-08-02 |
| Catalog Number | 399.38 |
| Lot Number | 4615664 |
| ID Number | (01)10886982202772(10)4615664 |
| 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 | 2016-07-05 |