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 2017-03-29 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE 399.40 manufactured by Synthes Usa.
[71228808]
Device used for treatment, not diagnosis. No patient involvement reported. Date of event: unknown. (b)(4). Device is an instrument and is not implanted/explanted. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. The device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. A service history evaluation/review was attempted. The investigation of the complaint articles has shown that: a request to complete part# 399. 40 lot unknown is required. 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
[71228809]
Device report from synthes on an event in (b)(6) as follows: it was reported that the handle of a periosteal elevator was split in two. There is 1 device in this complaint this report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[73682120]
Device was used for treatment, not diagnosis. A product development investigation was performed for the subject device (periosteal elevator 6mm curved blade-straight edge, part number 399. 40, lot number 9191). The subject device was returned with the complaint condition stating: the returned device was confirmed to have a broken handle where the dowel pin comes through the handle. Additionally, the distal tip is worn and chipped. No other issues were noted. A visual inspection and drawing review were performed as part of this investigation. The complaint is confirmed. Replication of the complaint condition is not applicable as the device is already broken. The dhr is not available as device is older than 20 years. In addition to the reported issue the distal tip was found to be worn and chipped. Drawings were reviewed during investigation. The design history was not found to impact the complaint condition. 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 the intended use when employed. A design clinical and risk management (dcrm) review and/or occurrence rate calculation must be performed for all complaint parts which resulted in a classification of serious injury that were not generated from a literature article. Therefore, no dcrm calculation will be performed for this complaint. It is likely that over 20 years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition. A device history record review (dhr) was performed for the subject device lot number 9191. Manufacturing location: unknown. Date of manufacture: unknown. Dhr not available as device is older than 20 years. At this time the manufacturing documents for instruments had to be stored for 10 years. 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
[74533692]
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
[74533693]
It was further reported that the hospital discovered the broken handle upon inspection during cleaning/sterilization.
Patient Sequence No: 1, Text Type: D, B5
[75226003]
No service history review can be performed because the lot/serial number cannot be traced as the device is older than 20 years. At this time the manufacturing documents for instruments had to be stored for 10 years. This was according to filing and archiving of specification documents, which was in place till (b)(6) 2014. The manufacture date is unknown. The service history review is unconfirmed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2017-11111 |
| MDR Report Key | 6443447 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-07 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-03-29 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2017-03-29 |
| Returned To Mfg | 2017-04-04 |
| Catalog Number | 399.40 |
| Lot Number | 9191 |
| 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 USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESER US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-29 |