MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-10-09 for 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM 292.68 manufactured by Synthes Elmira.
[3028940]
It was reported by the hospital facility; hospital received their purchase order p. O. (b)(4) and the 2. 4mm threaded guide wire- trochar point was found punched through the protective plastic tube and the bag housing the product.
Patient Sequence No: 1, Text Type: D, B5
[10399618]
Review of the dhr shows no compliant related anomalies. Package was returned damaged as stated. The sharp end of the product is poking through the inner tube as well as the outer packaging. This was a non-sterile package, so the product was never intended to be sterile, however, the integrity of the product and it's intended use may have been compromised.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003506883-2012-00303 |
| MDR Report Key | 2823592 |
| Report Source | 06,07 |
| Date Received | 2012-10-09 |
| Date of Report | 2012-09-11 |
| Date of Event | 2012-09-11 |
| Date Mfgr Received | 2012-09-11 |
| Device Manufacturer Date | 2012-08-28 |
| Date Added to Maude | 2013-01-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES ELMIRA |
| Manufacturer Street | 35 AIRPORT RD. |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM |
| Generic Name | THREADED GUID WIRE |
| Product Code | LYT |
| Date Received | 2012-10-09 |
| Returned To Mfg | 2012-09-20 |
| Catalog Number | 292.68 |
| Lot Number | 7013875 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES ELMIRA |
| Manufacturer Address | HORSEHEADS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-09 |