MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-19 for SYSTEM 5 DRILL manufactured by Stryker Instruments.
[55023394]
Patient Sequence No: 1, Text Type: N, H10
[55023395]
During a total joint procedure, a system 5 drill was used with 6 batteries during the case- none of the batteries held charge, although they were charged and sterilized per parameters. Another system 5 drill was offered to see if it was the drill or the batteries, but the surgeon deferred to continue to work with present drill as he was almost complete with his surgical cuts. After the procedures, the drills were tested and neither drill seemed to have audible torque, although torque is difficult to assess unless being used on patient. The company rep was contacted to assess the quarantined drills for further evaluation. All batteries have been recharged to their limit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5959555 |
| MDR Report Key | 5959555 |
| Date Received | 2016-09-19 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-07-26 |
| Report Date | 2016-08-26 |
| Date Reported to FDA | 2016-08-26 |
| Date Reported to Mfgr | 2016-08-26 |
| Date Added to Maude | 2016-09-19 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | SYSTEM 5 DRILL |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2016-09-19 |
| Returned To Mfg | 2016-07-26 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-19 |