MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-30 for 2.4MM DRILL BIT/QC/100MM 310.530 manufactured by Wrights Lane Synthes Usa Products Llc.
[146514609]
Exact date is unknown. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. Product was not returned. Device history records review could not be completed without lot number. Based on the information available, it has been determined that no corrective and preventative action is proposed. 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. 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
[146514610]
It was reported that on an unknown date while doing a total hip arthroplasty, the surgeon was drilling some holes for suture passing. The drill bit ended up breaking and remains in the patient. Additionally, surgeon stated that the flutes on the drill bit have a weird pattern. They are not barber poled like most drill bits. There were fragments generated, they are not removed, and no additional intervention performed. It is unknown if there was a surgical delay. Procedure was successfully completed. Patient outcome was unknown. This report is for one (1) drill bit. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-58379 |
| MDR Report Key | 8654434 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-06-24 |
| Device Manufacturer Date | 2017-01-06 |
| Date Added to Maude | 2019-05-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.4MM DRILL BIT/QC/100MM |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2019-05-30 |
| Returned To Mfg | 2019-05-31 |
| Model Number | 310.530 |
| Catalog Number | 310.530 |
| 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 | 2019-05-30 |