MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-12 for SYNTHES 2.5MM 110MM 310.25 manufactured by Synthes (usa) Products Llc.
[99795659]
Patient Sequence No: 1, Text Type: N, H10
[99795660]
During orthopedic surgical procedure, the doctor was drilling using a 2. 5 drill bit and the tip of the drill bit broke off in the patient's left humerus. The doctor was unable to retrieve the broken piece. A clinical decision was made to retain the object because removing it would do more harm to the patient then retaining the object. There was no harm to patient nor special monitoring required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7263020 |
| MDR Report Key | 7263020 |
| Date Received | 2018-02-12 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-19 |
| Report Date | 2018-02-01 |
| Date Reported to FDA | 2018-02-01 |
| Date Reported to Mfgr | 2018-02-01 |
| Date Added to Maude | 2018-02-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNTHES |
| Generic Name | BIT, SURGICAL |
| Product Code | GFG |
| Date Received | 2018-02-12 |
| Model Number | 2.5MM 110MM |
| Catalog Number | 310.25 |
| ID Number | 2.5MM 110MM |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) PRODUCTS LLC |
| Manufacturer Address | 1301 GOSHEN PKWY. WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-12 |