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 2017-11-06 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Synthes Tuttlingen.
[92200635]
No patient involvement was reported. Date of device breakage is not known. Device is an instrument and is not implanted/explanted. Dhr review: dhr not available as device is older than 15 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 august 2014. Customer quality (cq) engineering investigation: this complaint is confirmed. A distal portion of the handle has broken off and was not returned. The approximate size of the missing chunk of handle is 8mm x 11mm x 6mm. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken. No new malfunctions were identified as a result of the investigation. However, complaint category of "nicked/gouged/chipped" was selected at the time of complaint intake based upon the reported information, the failure code of "broken : procedural step unknown" was selected for this investigation summary to account for the as received condition of the device at cq. A visual inspection under 5x magnification and drawing review were performed at cq for the returned device as part of this investigation. No product design issues or discrepancies were observed. Visual inspection at cq confirmed the reported complaint condition. A distal portion of the handle has broken off and was not returned. The approximate size of the missing chunk of handle is 8mm x 11mm x 6mm. The entire device shows cumulative wear commensurate with over 15 years of field use and repeated sterilization cycles. Dhr review : part #: 399. 36 - lot #: 6019. Dhr not available as device is older than 15 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 august 2014. A material check or hardness check or dimensional inspection were not performed at cq as there is no indication that the material or hardness or dimensions would have contributed to this complaint for this 15+ year old reusable instrument breaking. Periosteal elevator assembly drawings were reviewed during this investigation. No product design issues or discrepancies were observed. Most likely due to over 15 years of cumulative wear and repeated sterilization cycles and possibly using the device as a lever ultimately degrading the handle material. 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
[92200636]
It was reported that a chunk of the periosteal elevator 6 mm curved blade-round edge device was gouged out. The piece is missing where the instrument is attached to the handle. That missing piece was unable to be found. The sales consultant is not sure when it occurred. This happened outside of surgery. There was no patient involvement. Evaluation of the returned device revealed a distal portion of the handle has broken off. Event was reassessed based on evaluation results and deemed to be reportable. This report is for one (1) periosteal elevator 6 mm curved blade-round edge this is report 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680938-2017-10139 |
| MDR Report Key | 7003031 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-06 |
| Date of Report | 2017-09-07 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-11-06 |
| 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 | 2017-11-06 |
| Returned To Mfg | 2017-09-18 |
| Model Number | 399.36 |
| Catalog Number | 399.36 |
| Lot Number | 6019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-11-06 |