MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-11 for 2.5 DRILL BIT WITH QUICK COUPLING/180MM SD310.230 manufactured by Wrights Lane Synthes Usa Products Llc.
[119850782]
Patient date of birth, sex and weight was not provided for reporting. Date of event is unknown. Device is an instrument and is not implanted / explanted. Reporter is synthes sales representative. (b)(4). The device was received, and the product evaluation is in progress. No conclusion can be drawn. Additionally, device history records review has been requested. 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
[119850783]
It was reported that on an unknown date in (b)(6) 2018, patient underwent surgery for a trauma case with a broken pelvis. During the surgery, four (4) drill bits with quick coupling broke at the exact same spot. The surgeon was getting an unknown screw in the pelvis and did not have many chances. Surgeon had to risk not getting proper fixation due to the drill bit breakage. Patient had to receive a different operative plan. Reportedly, four drill bit tips remained in the patient. The procedure was completed with 30 minutes surgical delay. Patient outcome is unknown. This report is for one (1) 2. 5 drill bit with quick coupling/180mm. This is report 2 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53721 |
| MDR Report Key | 7865143 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-23 |
| Date Mfgr Received | 2018-10-12 |
| Device Manufacturer Date | 2018-05-15 |
| Date Added to Maude | 2018-09-11 |
| 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 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.5 DRILL BIT WITH QUICK COUPLING/180MM |
| Generic Name | BIT MILLING STERILE AND NON |
| Product Code | GFG |
| Date Received | 2018-09-11 |
| Returned To Mfg | 2018-08-31 |
| Model Number | SD310.230 |
| Catalog Number | SD310.230 |
| Lot Number | H583944 |
| 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 | 1. Required No Informationntervention | 2018-09-11 |