MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE HYDRAULIC PUMP; GUIDE, NEEDLE, SURGICAL

Catalog Number 283906100

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

• Brand Name: CONFIDENCE HYDRAULIC PUMP
• Type of Device: GUIDE, NEEDLE, SURGICAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONSL SARL; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount dr; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7487160
• MDR Text Key: 107999145
• Report Number: 1526439-2018-50453
• Device Sequence Number: 1
• Product Code: GDF
• UDI-Device Identifier: 10705034209562
• UDI-Public: (01)10705034209562
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 283906100
• Device Lot Number: 167493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1