MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-31 for ROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL 03.607.009 manufactured by Synthes Hagendorf.
[81609899]
Patient information is not available for reporting. Udi: (b)(4). Implant and explant dates: device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter's telephone: (b)(6). 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
[81609900]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported during an unknown surgical procedure on (b)(6)2017, the rod introduction pliers broke. All fragments were retrieved. Surgery was completed successfully with a delay of approximately one (1) hour. No patient harm was reported. Concomitant devices reported: wire (part number unknown, lot number unknown, quantity 1). This report is for one (1) rod introduction pliers for uss polyaxial. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003875359-2017-10374 |
| MDR Report Key | 6754919 |
| Date Received | 2017-07-31 |
| Date of Report | 2017-07-04 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-09-20 |
| Device Manufacturer Date | 2014-05-22 |
| Date Added to Maude | 2017-07-31 |
| 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 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL |
| Generic Name | PLIERS, SURGICAL |
| Product Code | HTC |
| Date Received | 2017-07-31 |
| Returned To Mfg | 2017-08-18 |
| Catalog Number | 03.607.009 |
| Lot Number | 8929293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-31 |