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 2018-08-24 for 3.5MM TI LOCKING SCREW SELF-TAPPING 42MM 413.042 manufactured by Oberdorf Synthes Produktions Gmbh.
[118149138]
Patient weight was not provided for reporting. Additional device product code: ktt. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. 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
[118149139]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2014, patient underwent implant procedure for lower leg fracture. Patient was treated with angle-stable plate, distal tibia and one-third tubular plate, left. On (b)(6) 2016, patient underwent planned removal surgery. During the removal surgery, plate and screws from the fibula were removed without any issue. However, it was not possible to remove the screws with the screwdriver from the plate that was used in the tibia. For this, surgery was takeover by head doctor. First, the distal portion of the plate was presented extensively. It was then nevertheless necessary to hold the vena saphena magna between two overholt clamps, to separate and to ligate them. Now also the main incision in the area of the cranial portion up to the plate. Free preparation of all screws; these also could not be loosened using the screwdriver. In the course of things, from the cranial to the distal, screw heads were first drilled successively, then the screws were drilled out circumferentially with a retriever and the screws were hidden either by pliers, screwdriver, or by drilling. For this reason, at the screw removal site, there were respectively overboring defects, which in the further course of things were filled by endobone, as well as, in the distal portion, by bone fluid. Because of the drilled screw head, the sharp edges of the screws reached over the bone level. A straightening was not possible. Because of this, decision was made about the complete removal of the screw portions. An instability could not be established intraoperatively. Patient outcome was reported as stable. Concomitant devices reported: ti one-third tubular plate with collar 12 holes/145mm (part# 441. 420, lot# unknown, quantity 1); screwdriver (part# unknown, lot# unknown, quantity 1). This report is for one (1) 3. 5mm ti locking screw self-tapping 42mm. This is report 13 of 14 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-55949 |
| MDR Report Key | 7813501 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-24 |
| Date of Report | 2018-08-06 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2018-08-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM TI LOCKING SCREW SELF-TAPPING 42MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-08-24 |
| Catalog Number | 413.042 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-24 |