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 2020-03-31 for 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS 03.025.040 manufactured by Oberdorf Synthes Produktions Gmbh.
[186735295]
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
[186735296]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent a surgery. During the surgery, the drill bit interfered with the nail. The surgeon drilled a pilot hole with a k-wire, and he could drill and insert a screw. The surgeon didn't know concrete malfunction of the devices. It was not reported how the surgery was completed. The surgical delay was unknown. Concomitant devices reported: connect-scr-cann f/pfn+pfna (part# 357. 029, lot# 2223477, quantity#. This complaint involves seven (7) devices. This is report 3 of 7 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02432 |
| MDR Report Key | 9904362 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2017-09-28 |
| Date Added to Maude | 2020-03-31 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS |
| Generic Name | MISC ORTHO SURGICAL INSTR |
| Product Code | LXH |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-24 |
| Catalog Number | 03.025.040 |
| Lot Number | L561859 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-31 |