MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for CONFIDENCE HYDRAULIC PUMP 283906100 manufactured by Medos International Sàrl Ch.
[107999145]
(b)(4). Visual examination of the hydraulic pump revealed that the pump's tube has broken into two pieces, with the handle mechanism attached to one of the main pieces. Also, the hose connecting the hydraulic cylinder and the rectus connector is separated. No difficulties engaging and disengaging the rectus connector and the quick-connect feature of the cement reservoir connection were detected. Visual observations identified that there was hardened cement inside the confidence injector body. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting. The root cause of the pump breaking during use cannot be determined from the sample and the information provided. A potential root cause may be imperfections cause while staking the pump? S tube to the inside of the body of the pump. Functional analysis of the hydraulic pump revealed no difficulties engaging and disengaging the rectus connector and the quick-connect feature of the cement reservoir connection. Therefore, this investigation could not verify or identify any evidence of product contribution to the reported problem. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required. 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
[107999146]
It was reported that on (b)(6) 2018, the support staff had mixed the cement and they were getting ready to attach the cap to the vial and the metal connector would not latch on to the cap. Scrub personnel and surgeons all tried without success. It was deemed useless and a new complete box was opened. Cement only has a life of 9 minutes, so they could not use the cement due to this failure. All scrub personnel and surgeons used new clean over gloves when dealing with the cement. Surgical delay and patient outcome unknown. Concomitant devices reported: confidence spinal cement system (part # 283910000, lot # 163392, quantity # 1). This complaint involves one (1) device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50453 |
| MDR Report Key | 7487160 |
| Date Received | 2018-05-04 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-04-23 |
| Device Manufacturer Date | 2017-11-28 |
| Date Added to Maude | 2018-05-04 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808201 |
| Manufacturer G1 | MEDOS INTERNATIONSL SARL |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONFIDENCE HYDRAULIC PUMP |
| Generic Name | GUIDE, NEEDLE, SURGICAL |
| Product Code | GDF |
| Date Received | 2018-05-04 |
| Returned To Mfg | 2018-04-25 |
| Catalog Number | 283906100 |
| Lot Number | 167493 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-04 |