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 2018-08-01 for DHS?/DCS? LAG SCREW 14.0MM THREAD/95MM 280.495 manufactured by Oberdorf Synthes Produktions Gmbh.
[115704333]
Patient height reported as 169. 0 cms. Patient identifier not available for reporting. Additional product code: ktt. Device malfunctioned intra-operatively and was not implanted / explanted. Initial reporter telephone not available for reporting. A review of the device history records has been requested. Subject device has been received and is currently in the evaluation process. 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
[115704334]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient underwent a procedure to treat a femoral neck fracture on (b)(6) 2018 with plate and screws. During the procedure surgeon first used dynamic hip and condyler screw (dhs/dcs) lag screw on locking compression (lcp) plate, but there was failure as surgeon didn? T notify the screw diameter. Several attempts were made to remove the screw. Then surgeon used another dhs/dcs screw with the plate. During the procedure the dhs/dcs connecting screw broke inside dhs/dcs screw. All broken off fragments were removed from the patient. Surgery was delayed for unspecified amount of time due to reported event. Procedure was completed successfully with no patient consequences reported. Patient outcome reported as good. Preliminary evaluation of the returned devices revealed that both lag screws were expanded and damaged. Concomitant devices reported: dhs/dcs lag screw 12. 7mm thread/60mm (280. 600, lot l261421, quantity 1), 130 degree lcp dhs plate standard barrel 3 holes/76mm (02. 224. 203s, lot l806668, quantity 1), dhs/dcs lage screw 14. 0mm thread/90mm (280. 490, lot 9882468, quantity 1). This report is for one (1) 14mm dhs/dcs lag screw 95mm. This is report 2 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-55412 |
| MDR Report Key | 7739489 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-01 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-08-27 |
| Device Manufacturer Date | 2016-05-25 |
| Date Added to Maude | 2018-08-01 |
| 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 | ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DHS?/DCS? LAG SCREW 14.0MM THREAD/95MM |
| Generic Name | APPLIANCE,FIXATION DEVICE,PROXIMAL FEMUR |
| Product Code | JDO |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2018-07-13 |
| Catalog Number | 280.495 |
| Lot Number | H106232 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-01 |