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

Catalog Number 03.812.003

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records was conducted.The report indicates that the: part # 03.812.003 / lot # 3746775, lot number of part 03.812.003 is either 3746775 or 9271819.Manufacturing location: (b)(4), manufacturing date: 19 april 2011, no ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Part # 03.812.003 / lot # 9271819, manufacturing location: (b)(4), manufacturing date: 17 february 2015.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Manufacturing location: (b)(4).Manufacturing date: 16 october 2014.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute 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.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the t-pal applicator inner shaft broke during surgery on (b)(6) 2016.The surgeon was hammering the implant which was connected to the applicator shaft into the patient.He felt that the implant began to rotate on its pivot point prior to him release the pivot mechanism.When he had finished positioning the implant, he attempted to release the implant from the applicator by rotating the applicator knob as described in the surgical technique.The implant would not release from the applicator.To ascertain further why this was happening he removed the applicator knob and outer applicator 03.812.001, while leaving the inner applicator insitu.It was then clear that the inner applicator was bent and had snapped which caused the hook device on the inner applicator to not release from the implant.A considerable amount of time of approximately 50 minutes was spent trying to release the inner shaft from the implant without success.The surgeon then decided to use a high speed drill to cut through the peek implant in order to release the applicator.All broken off pieces were removed from the patient.There was no patient harm, patient went home and has been doing extremely well since incident.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot number 9082920.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The device manufacture date was oct 16, 2014.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Manufacturing investigation evaluation: the article is in a used condition.The fork at the end of the shaft is bent and one (1) piece of it is broken off.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacturing of the product.The damaged fork head was straightened first in order to make it possible to use gages to test the function of the applicator inner shaft.After this preparation, the functional test was executed.The applicator inner shaft passed the applicable tests.Further the hardness tests were conducted with a value of 51.2 hrc, which is within the specification of 48 - 52 hrc.There were no references to the reported issue.A mishandling of the t-pal applicator cannot be excluded, which could have led to the heavy deformations and broken fork head.No manufacturing related issues were identified and/or confirmed product investigation summary: the manufacturing documents of the received t-pal applicator inner shaft were reviewed with no complaint related issues detected.A manufacturing evaluation of the received shaft was performed and no deviation from the specifications could be detected.Although the fork of the shaft was badly damaged, it was possible to perform a functional test.Based on the findings, a manufacturing related issue could be excluded.It is obvious that this inner shaft was exposed to very high forces, but afterwards it cannot be defined if this occurred during insertion or extraction.According to the description, it was mentioned that the implant began to rotate before the mechanism was released.Also, it was finally not possible to remove the hook as it was bent and snapped.This could be an indication that the implant may not have been properly inserted as the arrows on the end of the applicator were not aligned with the arrows on the implant.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.

• Brand Name: T-PAL SPACER APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBAL 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5419362
• MDR Text Key: 37781040
• Report Number: 3003875359-2016-10083
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151276
• 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,Followup,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.003
• Device Lot Number: 9082920
• Other Device ID Number: (01)07611819414600(10)9082920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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
• Patient Outcome(s): Required Intervention