MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH APPLICATOR INNER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.003

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part 03.812.003, lot l349051: release to warehouse date: may 15, 2017.Manufacturing site: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: three parts were returned (03.812.001 (lot 9751114), 03.812.003 (lot l349051), 03.812.004 (lot l000240).All are in a sound condition and show normal signs of usage.The distal end of the t-pal inner shaft (03.812.003) is slightly bent outwards.Regarding the function of the instrument a functional test was done with a t-pal peek cage (part 08.812.017, lot 3765095).Assembling, disassembling and attaching/detaching of the implant could be done without any issues.The review of the production histories revealed that these instruments were manufactured according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The exact cause of failure could not be determined.As mentioned in the complaint description several things could have contributed to this complaint.Per surgical technique guide, the usage of a trial implant is recommended to determine the correct size of the implant.As this was not done, the correct size of the final implant is not guaranteed.The following heavy hammering is another indicator that the implant size was probably too thick.The outwards bent finger like catchers of the inner shaft and the problems with disengaging the implant from the applicator inner shaft are eventually the result of a wrong angle between the applicator handle and the sagittal plane during implant insertion.Device was 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that to prepare the disc space for the insertion of the tlif cage, the surgeon used kerrisons and rongeurs.After that, the surgeon used the t-pal shavers and determined that the definitive implant cage should be a tpal small 10mm; no trial implants were used.Once filled in with autolog bone from the patient and loaded on the tpal inserter, the cage was given to the surgeon for implantation.To insert the cage, some heavy hammering was needed.To both help the cage progress and rotate, in several occasions the t-pal inserter was hammered while maintaining the applicator handle medially.Under fluoroscopy, the cage was positioned according to the surgical technique recommendations.To release the cage, the surgeon pushed the security ring down and turned the handle counterclockwise until it stopped.The applicator did not disengage from the implant.To help with removing the instrument, the surgeon decided to disassemble the handle and external applicator to leave only the internal applicator.Then he was able to remove the instrument.However, the cage had moved back.With the instrument 394.572, the surgeon tried to reposition and push the implant but it did not work.The surgeon decided to leave the cage partially rotated.There were no patient consequences.Concomitant devices: graft pusher (part 394.572, lot unknown, quantity 1); hammer (part/lot unknown, quantity 1) this is report 2 of 4 for (b)(4).

Manufacturer Narrative

Device was 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

There was approximately 15-20 minutes surgical delay due to time required to disassemble the instrument, remove it from patient, try repositioning the implant, and check with x-ray.Surgery was completed successfully except that the cage could not be perfectly positioned according to surgical technique recommendations.

• Brand Name: APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7153980
• MDR Text Key: 96218154
• Report Number: 8030965-2017-51001
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819414600
• UDI-Public: (01)07611819414600(10)L349051
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.003
• Device Lot Number: L349051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1