MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-20 for 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM 212.111 manufactured by Wrights Lane Synthes Usa Products Llc.
[186275802]
Complainant part is not expected to be returned for manufacturer review/ investigation. 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
[186275803]
It was reported that on an unknown date, a patient fell resulting in a displaced right proximal humerus fracture. On (b)(6) 2009, the patient underwent an open treatment of right proximal humerus fracture with tuberosity repair. Plate and screws were implanted. After the procedure, the patient experienced a reaction at the surgical site for five (5) years. The patient wants the devices removed. At this point no revision procedure has been reported. Concomitant devices: 3. 5mm lcp? Proximal humerus plate-standard 5h shaft/ 114mm (part 241. 903, lot unknown, quantity 1); 3. 5mm locking screw slf-tpng w/stardrive(tm) recess 45mm (part 212. 119, lot unknown, quantity 3); 3. 5mm locking screw slf-tpng w/stardrive(tm) recess 40mm (part 212. 117, lot unknown, quantity 1); 3. 5mm cortex screw self-tapping 26mm (part 204. 826, lot unknown, quantity 3); 3. 5mm cortex screw self-tapping 24mm (part 204. 824, lot unknown, quantity 1); 3. 5mm locking screw slf-tpng with stardrive recess 35mm (part 212. 114, lot unknown, quantity 1). This report is for an lcp screw. This is report 5 of 10 for (b)(4). An additional device is captured on related complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01430 |
| MDR Report Key | 9861902 |
| Report Source | OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM |
| Generic Name | NAIL, FIXATION, BONE |
| Product Code | JDS |
| Date Received | 2020-03-20 |
| Model Number | 212.111 |
| Catalog Number | 212.111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |