MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-05-18 for WASHER, BOLT, NUT, NON-SPINAL, CETALLIC manufactured by Synthes (usa).
[75500567]
510k: this report is for an unknown washer. Part and lot numbers are unknown; udi number is unknown. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[75500568]
It was reported that patient underwent an open reduction internal fixation (orif) of the proximal tibia on an unknown date. The original construct included one (1) 4. 5mm lateral proximal tibia plate, six (6) screws in the plate and one (1) independent 7. 3mm cannulated screw with a washer. Subsequently, the patient complained of pain at the medial side of the tibia, where the independent 7. 3mm cannulated screw had been implanted. Patient was returned to surgery on (b)(6) 2017 for hardware removal. The surgeon was able to remove the 7. 3mm cannulated screw and washer and two (2) proximal locking screws in the plate -all intact. One (1) proximal screw stripped and the surgeon decided to stop trying to remove hardware. The stripped screw remained implanted. Retained hardware included the 4. 5mm lateral proximal tibia plate, one (1) proximal screw and three (3) distal screws. All hardware was intact. There was no reported surgical delay, and no additional x-rays or additional medical intervention required. The proximal screw that stripped is reported in (b)(4). This report is for one (1) washer. This is report 2 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-11669 |
| MDR Report Key | 6577104 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-18 |
| Date of Report | 2017-04-21 |
| Date Mfgr Received | 2017-04-21 |
| Date Added to Maude | 2017-05-18 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WASHER, BOLT, NUT, NON-SPINAL, CETALLIC |
| Product Code | NDG |
| Date Received | 2017-05-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-18 |