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 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 60MM FOR IM NAILS 04.005.550 manufactured by Oberdorf Synthes Produktions Gmbh.
[186117864]
Event is reported as 2019, exact date of post-operative screw breakage is unknown. Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received. Reporter is a synthes employee. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. 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
[186117865]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient was implanted with retrograde/ antegrade femoral nail (rafn) 9mm x 400 mm, and 5. 0 mm locking screws (76mm x 1, 60mm x 1 and 32 mmx1). On (b)(6) 2019, the patient was readmitted due to the backed out 76mm screw. The 76mm screw was removed successfully. Post-op, when patient was doing physiotherapy and rehabilitation, patient started feeling pain again. Post-op x-ray was performed on an unknown date. The x-ray showed that the 60mm distal screw was broken, and this caused the nail to back out. The 60 mm screw remains in the patient. Patient has not returned for follow-up. Patient outcome is unknown. This report captures post-op breakage of 60mm distal screw while related complaint (b)(4) captures post-op event of backing out of 76mm screw. Concomitant devices reported: rafn nail (part number unknown, lot unknown, quantity 1), and 32 mm locking screw (part number unknown, lot unknown, quantity 1). This report involves one (1) 5. 0mm ti locking screw w/t25 stardrive 60mm for im nails. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02426 |
| MDR Report Key | 9903704 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-03-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 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 | 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 60MM FOR IM NAILS |
| Generic Name | SCREW,FIXATION,BONE |
| Product Code | HWC |
| Date Received | 2020-03-31 |
| Catalog Number | 04.005.550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-31 |