MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-10-24 for DRILL BIT 1 L46/34 2FLUTE 513.005 manufactured by Synthes Usa.
[2925958]
A device report from synthes (b)(4) indicated a hospital in (b)(6) reported: during a left humerus fracture procedure, the drill bits fractured during the perforation process with the air pen drive. There was no issue recognized with the air pen drive. Surgeon used kirschner wires instead of plate and screws. The location of the three broken drill bit tips is unk. It was confirmed that the 4th broken drill bit tip was not left in the pt. This is #2 of 4 reports for the same event.
Patient Sequence No: 1, Text Type: D, B5
[3042420]
A piece of one of the drill bits was left within the patient; however, the patient is reportedly in perfect condition after surgery.
Patient Sequence No: 1, Text Type: D, B5
[10255842]
Investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system. A review of the device history records has been requested.
Patient Sequence No: 1, Text Type: N, H10
[10341725]
Manufacturing documents were reviewed and no complaint related issues were found. The measurable dimensions of the broken drill bits were checked and found to be in compliance with the technical drawings and ao/asif specification. The examination of the raw material testing certificates and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability. The values were in compliance with ao/asif specification and with the international standard. An exact cause for this occurrence could not be determined. It can only be assumed that too much mechanical force had been applied during the surgery, i. E. Too high drill speed, hard bone or possible movement in a slanting position. These are very delicate drill bits which require extra caution during use. No product fault could be detected. Date of manufacture determined from lot number of the device.
Patient Sequence No: 1, Text Type: N, H10
[10541511]
This device is used for treatment, not diagnosis. (b)(4): during a review of the event it was determined the event should have been a reportable malfunction not an adverse event. (b)(4): placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-02544 |
| MDR Report Key | 2815396 |
| Report Source | 01,07 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-09-24 |
| Date of Event | 2012-09-12 |
| Date Mfgr Received | 2013-01-16 |
| Device Manufacturer Date | 2011-12-09 |
| Date Added to Maude | 2012-11-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SARMA PIN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL BIT 1 L46/34 2FLUTE |
| Generic Name | DRILL BIT |
| Product Code | HTT |
| Date Received | 2012-10-24 |
| Returned To Mfg | 2012-10-05 |
| Catalog Number | 513.005 |
| Lot Number | F-12395 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-24 |