MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for MILLING BIT HXC-STERILE 03.820.153S manufactured by Wrights Lane Synthes Usa Products Llc.
[105160149]
Device used for treatment, not diagnosis. (b)(6). Patient weight not provided for reporting. Device is an instrument and malfunctioned intra-operatively and was not implanted / explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Device history records review was requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. Investigation summary: dhr review could not be conducted due the insufficient information? S. Product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable.
Patient Sequence No: 1, Text Type: N, H10
[105160150]
It was report that the patient had original surgery on (b)(6) 2018 for treatment of a spine cervical artificial disc replacement (pdc) implant at c5-c6 disc levels. Patient was implanted with one (1) level unknown pdc implant. Inter-operatively, it was reported that a milling bit hxc instrument tip broke during the procedure. After the surgeon had completed the superior keel cut, the milling bit was placed in the inferior keel port. The bit tip broke after milling was only about 80% complete. No harm was reported to the patient. The milling bit was removed by removing the guide and the keel cut was completed using a chisel. The case proceeded without issue. Surgery was completed successfully with no time delay. Patient is reported in stable condition. Reporter has no more information to report on this event. Concomitant device unknown artificial disc replacement pdc (item # unknown, lot # unknown, quantity 1 each). This report is for one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-51492 |
| MDR Report Key | 7401680 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-03-12 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2014-05-22 |
| Date Added to Maude | 2018-04-05 |
| 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MILLING BIT HXC-STERILE |
| Generic Name | BIT |
| Product Code | GFG |
| Date Received | 2018-04-05 |
| Catalog Number | 03.820.153S |
| Lot Number | 7604638 |
| Device Expiration Date | 2019-04-30 |
| 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 | 2018-04-05 |