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 2018-05-02 for TRAUMACEM(TM) V+ INJECTION CANNULA FOR TFNA - STERILE 03.702.121S manufactured by Oberdorf Synthes Produktions Gmbh.
[107106351]
Patient information is unknown. The 510k: this report is for an unknown traumacem v+ cement/unknown lot. Part and lot number are unknown; udi number is unknown. Device has not been reported as explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[107106352]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during augmentation of trochanteric fixation nail advanced (tfna) the traumacem v+ cement hardened quite fast. Because of this it was not possible to remove the cement cannula. It broke and part of the cannula remained in the blade. The surgery was prolonged about ten (10) minutes. There was no patient harm and the outcome was reported as normal. Concomitant device: tfna blade (part/lot unknown, quantity 1). This report is for unknown traumacem v+ cement. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-53497 |
| MDR Report Key | 7479625 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-02 |
| Date of Report | 2018-04-03 |
| Date Mfgr Received | 2018-06-22 |
| Date Added to Maude | 2018-05-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAUMACEM(TM) V+ INJECTION CANNULA FOR TFNA - STERILE |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-05-02 |
| Catalog Number | 03.702.121S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-02 |