MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-20 for VM RHOTON SELLA PUNCH 1 MM WIDE UPCUT 45 DEG NL3785-164 / 0110814 manufactured by S.u.a. Martin Gmbh &co.kg.
[112439546]
The device was manufactured in 1998 and the photographs provided by the distributor show signs of considerable wear. The manufacturer is awaiting return of the device to perform a complete evaluation.
Patient Sequence No: 1, Text Type: N, H10
[112439547]
Medwatch report states: #1 kerrison instrument used during posterior cervical instrumentation. Tip of kerrison noted to have broken off during procedure. Radiographic confirmation obtained that tip of instrument was not retained in patient. Suction filter was radiographed and tip found to be seated in filter of the suction machine. Cpd (central processing department) manager notified. Broken instrument isolated w/ suction filter and given to central processing department who dismantled suction filter and sifted piece out. What was the original intended procedure? : decompression and fusion posterior cervical spine one lever- c2-c7 fusion posterior cervical spine three or more levels- laminectomy cervical spine with decompression and instrumentation two levels patient was not harmed in this incident. On 11may2018 additional information: 1. Is it normal procedure to take an x-ray of the patient or was this only done to verify the location of the broken tip of the instrument? It is standard procedure to have c-arm (x-ray) in the room during this procedure. X-ray is used to confirm placement of instrumentation during and immediately prior to patient leaving the operating room (or).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010386-2018-00005 |
| MDR Report Key | 7619531 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 1998-03-31 |
| Date Added to Maude | 2018-06-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARKUS PAULI |
| Manufacturer Street | UHLANDSTRASSE 17 |
| Manufacturer City | RIETHEIM-WEILHEIM, 78604 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78604 |
| Manufacturer G1 | S.U.A. MARTIN GMBH &CO.KG |
| Manufacturer Street | UHLANDSTRASSE 17 |
| Manufacturer City | RIETHEIM-WEILHEIM, 78604 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VM RHOTON SELLA PUNCH 1 MM WIDE UPCUT 45 DEG |
| Generic Name | MANUAL RONGEUR |
| Product Code | HAE |
| Date Received | 2018-06-20 |
| Catalog Number | NL3785-164 / 0110814 |
| Lot Number | XMEA 03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S.U.A. MARTIN GMBH &CO.KG |
| Manufacturer Address | UHLANDSTRASSE 17 RIETHEIM-WEILHEIM, 78604 GM 78604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-20 |