MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-02-07 for BONE COLLECTOR B-COLLECTOR-1 manufactured by Depuy Synthes Power Tools.
[66779720]
(b)(4). The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. 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
[66779721]
This is report 2 of 2 for the same event: it was reported that during an unspecified surgical procedure, it was observed that the suction port stems separated from their respective collection chambers of two bone collector devices while the stems were still inside the suction tubing. The reporter was uncertain whether the devices separated before or after the stems were ready to be used to join the suction tubes together. The reporter stated that the breakage occurred at the central filter's snap-off union where the double male connection allowed for the joining of the two suction tube ends once the device was removed from between the two suction tubes. The reporter further stated that the user? Nurse? Was not yet trained on the proper usage of the device and therefore, applied too much pressure while connecting/disconnecting the suction tubing to the device, resulting in the device to snap-off. It was reported that the second device was pulled and the user repeated the same technique which resulted in another malfunction of the device. The reporter further stated that the issue occurred as a result of user error due to proper assembly and from applying too much pressure. There were no delays to the surgical procedure as spare devices were available to complete the surgery successfully. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[67682039]
Additional narrative: correction: upon further review of this complaint, it was determined that there was no alleged malfunction against the devices as they performed as intended by snapping off. Therefore, this complaint is not reportable. 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 | 1045834-2017-10344 |
| MDR Report Key | 6307067 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-07 |
| Date of Report | 2017-01-23 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-02-14 |
| Date Added to Maude | 2017-02-07 |
| 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 | RODNEY CRAIN |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5616271080 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE COLLECTOR |
| Generic Name | BONE PARTICLE COLLECTOR - BONE COLLECTOR |
| Product Code | MXP |
| Date Received | 2017-02-07 |
| Returned To Mfg | 2017-01-27 |
| Catalog Number | B-COLLECTOR-1 |
| Lot Number | 3019130831 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-02-07 |