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 2017-12-06 for 3.5MM RECONSTRUCTION PLATE 10 HOLES/118MM 245.00 manufactured by Wrights Lane Synthes Usa Products Llc.
[93837598]
Patient? S weight is unknown. Additional device product code: kwp. Complainant device is not expected to be returned for manufacturer. Review/investigation. 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
[93837599]
It was reported that a revision procedure was performed for ors right clavicle because the patient had a bicycle accident and re-injured himself on the same site. There was non-union and the plate was bent. The original plate was removed and a new plate was inserted. There was no surgical delay. Patient outcome was stable. Surgery was completed successfully. This report is for one (1) 3. 5mm reconstruction plate 10 holes/118mm. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[111066233]
A device history record review was performed for the subject device: part number: 245. 00 lot number: 4923725 part manufacture date: 28-jan-2005 manufacturing location: (b)(4) part expiration date: n/a. Nonconformance noted: n/a. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of 3. 5mm reconstruction plate 10 holes/118mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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
| Report Number | 2939274-2017-50155 |
| MDR Report Key | 7086447 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-06 |
| Date of Report | 2017-11-07 |
| Date Mfgr Received | 2018-01-05 |
| Device Manufacturer Date | 2005-01-28 |
| Date Added to Maude | 2017-12-06 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS 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 | 3.5MM RECONSTRUCTION PLATE 10 HOLES/118MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2017-12-06 |
| Model Number | 245.00 |
| Catalog Number | 245.00 |
| Lot Number | 4923725 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-12-06 |