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 2020-03-13 for UNK - DRILL BITS: TRAUMA manufactured by Wrights Lane Synthes Usa Products Llc.
[183728828]
This report is for an unk - drill bits: trauma/ unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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
[183728829]
It was reported that during an unknown procedure on an unknown date, the unknown 2. 0mm drill bit was broken and the broken portion was left in the patient. The surgeon requested an information on the material of the broken drill bit as he was concerned about the mri compatibility on the material. It is unknown if there was an adverse consequence on the patient. It is unknown if there was a plan for another surgery to remove the broken piece. This complaint involves one (1) device. This is 1 of 1 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01268 |
| MDR Report Key | 9831968 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - DRILL BITS: TRAUMA |
| Generic Name | DRILL BIT |
| Product Code | HTW |
| Date Received | 2020-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-13 |