MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/LT 03.123.011 manufactured by Wrights Lane Synthes Usa Products Llc.
[117847861]
Device is an instrument and is not implanted / explanted. Device is expected to be returned for manufacturer review/investigation but has not been received yet. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. 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
[117847862]
It was reported that on an unknown date, insertion guide screw, for the locking compression plate (lcp) periarticular proximal humerus plate broke. It was unknown if there was a procedure or patient involvement. This report is for one (1) insertion guide f/3. 5mm lcp periartic prox humerus pl/lt. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53362 |
| MDR Report Key | 7794718 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-30 |
| Date Mfgr Received | 2018-09-20 |
| Device Manufacturer Date | 2011-01-04 |
| Date Added to Maude | 2018-08-17 |
| 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 | 0 |
| Brand Name | INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/LT |
| Generic Name | GUIDE |
| Product Code | FXZ |
| Date Received | 2018-08-17 |
| Returned To Mfg | 2018-09-04 |
| Catalog Number | 03.123.011 |
| Lot Number | 6557510 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-17 |