MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER APPLICATOR KNOB; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.004

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.Reporting facility phone number is (b)(6).510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the reported subject device lot.Manufacturing location: (b)(4).Date of manufacture: sep 25, 2014.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 europe reported an event in (b)(6) as follows: it was reported that preoperatively the applicator knob and the applicator outer shaft could not be dismantled properly.The instruments became stuck together, therefore dismantling was difficult.There was no reported patient or procedural involvement.This report is 4 of 4 for (b)(4).

Manufacturer Narrative

The 510(k): statement in initial medwatch report (b)(4) reported that the device is not distributed in the usa but this statement is incorrect.As previously reported the device has a 510(k).This device is distributed in the usa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product development investigation was completed.A visual inspection, function test and device history records review were completed as part of this investigation.Our investigation has shown that the complained instruments are fully functional as required.The result of our functional tests has shown that the instruments are dismantling as required.Therefore, we cannot confirm that the instruments cannot be dismantling as mentioned in the complaint description.The articles were analyzed for conformance to print specifications, as well as the device history records were researched.No abnormal findings were identified.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.We assume that a mishandling of the opening/release feature was the reason for the malfunction.This is addressed in cleaning and sterilization guideline; lubricate instruments with moving parts, such as hinges and joints, spring-loaded ball bearings and threaded parts.Further investigation has shown that on the tips between fork and the bore hole some wear marks were visible.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.

• Brand Name: T-PAL SPACER APPLICATOR KNOB
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• 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: 6449475
• MDR Text Key: 71493848
• Report Number: 3003875359-2017-10157
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819414624
• UDI-Public: (01)07611819414624(10)9082945
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.004
• Device Lot Number: 9082945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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