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 2020-03-25 for GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1 292.620S manufactured by Oberdorf Synthes Produktions Gmbh.
[185938606]
Device is not distributed in the united states, but is similar to device marketed in the usa. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[185938607]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent open reduction internal fixation surgery for the tibia medial malleolar fracture with the guide wire in question. During surgery, the surgeon inserted 2 guide wires. The surgeon drilled one hole, but then had difficulty in drilling the second hole. After drilling, the surgeon inserted screws, and tried to remove the guide wires. When removing the second guide wire, the screw slightly came out and the tip of the guide wire was broken. Image intensifier showed the fragment of the guide wire remained in the bone. The surgeon decided to leave the fragment in the bone. The surgery was completed without any surgical delay. No further information is available. Concomitant device reported: unk - screws: cannulated: trauma (part # unknown, lot # unknown, quantity # unknown), unk - guides/ sleeves/aiming: sleeve (part # unknown, lot # unknown, quantity # unknown), unk - guides/ sleeves/aiming: guide (part # unknown, lot # unknown, quantity # unknown). This report is for one (1) guidewire 1. 25 w/thread-tip w/ trocar l1. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02295 |
| MDR Report Key | 9879500 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-03-25 |
| 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 PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| 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 | GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1 |
| Generic Name | WIRE,SURGICAL |
| Product Code | LRN |
| Date Received | 2020-03-25 |
| Catalog Number | 292.620S |
| Lot Number | 5L52418 |
| 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 | 2020-03-25 |