MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-23 for L-CLIP APPL/REMVR 90 MM RND HANDLE VAR 45.441 manufactured by Depuy Synthes Power Tools.
[16866020]
It was reported that a clip device would "not stay in the locked position". It was unknown to the reporter if the device was used in surgery. It was unknown to the reporter if there were any delays in a surgical procedure or if a spare device was available. It was unknown if injuries or medical intervention were reported. The date of the event was unknown but the reporter clarified that the event occurred in 2013. Several attempts have been made to obtain additional information concerning the reported event; however, no additional information has been provided. A supplemental medwatch report will be submitted if further information is received.
Patient Sequence No: 1, Text Type: D, B5
[17046932]
The device has not been returned as this is a single-use instrument; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[22088010]
The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the device would not stay in the locked position. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to misuse, abuse and/or user error. 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 | 1045834-2013-24039 |
| MDR Report Key | 3304758 |
| Report Source | 06 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-07-26 |
| Date Mfgr Received | 2014-09-05 |
| Date Added to Maude | 2013-11-21 |
| 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 | MR. RODNEY CRAIN |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5616271080 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L-CLIP APPL/REMVR 90 MM RND HANDLE VAR |
| Generic Name | NI |
| Product Code | HCI |
| Date Received | 2013-08-23 |
| Returned To Mfg | 2013-08-27 |
| Catalog Number | 45.441 |
| Lot Number | NI |
| 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 | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-23 |