MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for AIR PEN DRIVE 05.001.080 manufactured by Depuy Synthes Products Llc.
[186548845]
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. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the reported condition was confirmed. The assignable root cause was traced to improper maintenance. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186548846]
It was reported from (b)(6) that during service and evaluation, it was determined that the motor air pen drive device was worn. It was further determined that the device failed pretest for check valve-control in? Hand? Position with hand switch and check with test bench. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The date of event was unknown but was known to have occurred in 2020. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02303 |
| MDR Report Key | 9888839 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2011-09-08 |
| Date Added to Maude | 2020-03-27 |
| 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 | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES PRODUKTIONS GMBH |
| Manufacturer Street | HAUPTSTRASSE 24 |
| Manufacturer City | WALDENBURG 4437 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR PEN DRIVE |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT |
| Product Code | HWE |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-05 |
| Catalog Number | 05.001.080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |