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 2017-05-19 for DOUBLEAIRHOSE L5M F/SYST SYNTHES 519.530 manufactured by Depuy Synthes Power Tools.
[75512351]
(b)(4). The manufacturing location was unknown. Device manufacture date is unknown. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the device had general wear and the shaft was torn. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to premature wear from normal use and servicing. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[75512352]
It was reported from (b)(6) that the air hose device "bursted". This event did not occur during surgery. There was no patient involvement. There were no reports of any injuries, medical intervention or prolonged hospitalization. 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
[80146760]
The date the device was received was reported as april 28, 2017 in the initial report and has been updated to may 3, 2017. Additional information received on the device evaluation determined that the device outer green hose was torn. The assignable root cause was determined to be due to wear from normal use and servicing. 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
| Report Number | 8030965-2017-12443 |
| MDR Report Key | 6577717 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-19 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-04-24 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-05-19 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | NI |
| Manufacturer City | NI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLEAIRHOSE L5M F/SYST SYNTHES |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-05-19 |
| Returned To Mfg | 2017-04-28 |
| Catalog Number | 519.530 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | NI NI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-19 |