MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER APPLICATOR HANDLE; INTERVERTEBAL FUSION DEVICE

Catalog Number 03.812.001

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient¿s initials/identifier, age/date of birth and weight were not provided for reporting.Not explanted.Device is an instrument and is not implanted/explanted.Device history records review was conducted.The report indicates that the: part #03.812.001 / lot #8305053, manufacturing location: (b)(4), manufacturing date: 30.Apr.2013.No ncrs 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 manufacturing investigation was performed for the subject device: conclusion: received 1 article of applicator outer shaft, art.No.: 03.812.001, for manufacturing investigation.The instrument is in a used condition.On the tip of the shaft traces of use are present.Affected part: part description: applicator outer shaft, part number: 03.812.001, lot number: 8305053, lot size: 18, lot release date: 30.04.2013.For verification of the functionality the applicator outer shaft 03.812.001 was tested with functional gages 60056816 and 60056818.They simulate the handling with applicator inner shaft 03.812.003 and applicator knob 03.812.004.During surgery, all three instruments are used together.Further the thread of the applicator outer shaft 03.812.001 was tested by thread ring gages.All measured characteristics are within the specifications and additionally the article passed the functional test without any references to the reported issue.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.Function / tested with functional gages 60056818 (simulates applicator inner shaft 03.812.003) and 60056816 (simulates and applicator knob 03.812.004).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) 2017, surgery was performed using the t-pal cage system.During the surgery, the following issues were confirmed with t-pal spacer applicator handle and t-pal spacer applicator inner shaft.To correct the inserting direction, the surgeon took an action to pull out the spacer that was already sitting in the bone.He turned the handle to the state of ¿open¿, and then pulled out the spacer forcibly.The spacer was separated from the inner shaft and was left in the bone.Finally, the surgeon corrected the location of the cage using an impactor.The surgery was successfully completed with a 15-minute delay, and there was no adverse consequence to the patient.The procedure was completed successfully.The event that happened between the cage (part#:unk) and the inner shaft (part#: 03.812.003).Initially, the surgeon tried to pull the cage out in order to correct its inserting direction, and then the cage got separated from the inner shaft.Fortunately, the cage was sitting in a proper position, thus he successfully correct the inserting direction using the impactor (part#:unk).This complaint involves 5 parts.This report is 4 of 5 for (b)(4).

• Brand Name: T-PAL SPACER APPLICATOR HANDLE
• Type of Device: INTERVERTEBAL FUSION DEVICE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7004657
• MDR Text Key: 92494338
• Report Number: 3003875359-2017-10544
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819405813
• UDI-Public: (01)07611819405813(10)8305053
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.001
• Device Lot Number: 8305053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• 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