MAUDE Adverse Event Report: SYNTHES BRANDYWINE INFERIOR END PLATE MEDIUM-STERILE; PROSTHESIS INTERVERTEBRAL DISC

Catalog Number PDL-M-IP00S

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was not implanted during the surgical procedure on (b)(6) 2015.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacture date: january 16, 2015 - expiration date: october 31, 2019.Review of the device history records (including raw materials) indicates there were no issues with the endplate.There were no manufacturing discrepancies relevant to the complaint of ¿resulting patient harm.¿ the inspection sheet showed all parts passed visual and dimensional inspection requirements.The supplier initiated an incoming defect report (idr) for visual non-conformances on all (b)(4) parts prior to coating.The parts were processed normally and evaluated at incoming inspection where they all passed.The packaging label log showed that the required labels were present and met requirements.Review of operator inspection sheet indicates that this was the first lot packaged of the day.Review of inspection sheet shows that the quality check was performed and parts met process requirements.Raw material ¿ 41030 ¿ lot #4789792.The receipt traveler was reviewed for correct type, size, grade, shape, and jde/lot/heat number with no discrepancies found.Review of the inspection sheet showed that the material conformed to all dimensional, chemical content analysis, and recertification specifications.Packing lists contained the correct type, size, and heat number.Review of the vendor certification showed that the material was processed per synthes specification with non-conformities.Device used for treatment, not diagnosis.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 the medium inferior endplate would not load correctly onto the medium inserter during an initial surgical procedure on (b)(6) 2015.As a result, the implant would not go down far enough on the inserter's pins to rotate the arms into the locked position.When the scrub nurse and the surgeon tried to take the inferior endplate off, it remained stuck and would not disengage.A second medium inferior endplate and another medium inserter were then used to complete the surgery.The second implant reportedly loaded fine, but the surgery itself was delayed by fifteen (15) minutes.There were no fragments generated during the surgery.Following the procedure, the inserter with the stuck implant had been washed and the sales consultant tried detaching the devices without success.The hospital staff then peel packed the two devices and sterilized them.When they came out of sterilization, the two (2) parts had disengaged.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (part number pdl-m-ip00s, lot number 7797566, inferior end plate medium-sterile).The subject device was received with a complaint description stating that the inserter would not disengage from the associated inferior endplate during surgery but disengaged once sterilized.The medium inferior end plate is part of the prodisc-l total disc replacement system.The prodisc-l system is ¿intended to replace a diseased and/or degenerated intervertebral disc of the lumbosacral region¿ between l3 and s1 per the technique guide.The product drawings were reviewed during the investigation.These drawings were found suitable to determine the intended device design, application and dimensional conformity.The product was received under the complaint condition ¿device interaction: sticks/jams/stuck¿.When assembling the returned items during the investigation, there was some resistance from the arm without stopper when turning the arm to lock the inferior plate to the medium inserter.There was resistance when disengaging the inferior plate from the medium inserter.With this observation and the age of the medium inserter (over 10 years old), it is likely that one or both pins are slightly bent.The complaint condition was due to the inserter design as reported in the related follow up medwatch report for the inserter instrument.Although the complaint condition was confirmed, it is not related to the inferior endplate.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INFERIOR END PLATE MEDIUM-STERILE
• Type of Device: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5257323
• MDR Text Key: 32376512
• Report Number: 2530088-2015-10711
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: PDL-M-IP00S
• Device Lot Number: 7797566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1