MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER 10MM X 28MM 10MM HEIGHT¿STERILE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 08.812.010S

Device Problem Separation Failure (2547)

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.(b)(4).The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery to implant the t-pal system to treat spinal canal stenosis on (b)(6) 2016, the t-pal spacer applicator inner shaft was not able to detach the reported t-pal spacer after inserting and placing the spacer into the final position in the intervertebral disc space (l2-3).The surgeon removed the applicator shaft and spacer from the disc space.The surgical team then confirmed (outside the surgical site) that the applicator shaft could detach the spacer as expected.The surgeon tried to detach the spacer from the applicator shaft three more times but the spacer failed to detach.The surgery was extended for 30 minutes due the reported event.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Report should be product problem/malfunction only.There was no reported adverse event.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.

Manufacturer Narrative

Other udi: (b)(4).Device history records was conducted.The report indicates that the: 08.812.010s / 9854764, manufacturing location: (b)(4).Manufacturing date: 17th march 2016 expiry date: 1st march 2026.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.Subject device has been received and an investigation summary was performed.The investigation of the complaint articles has shown that: part 03.812.001 / #lot 8932962 / applicator outer shaft: part 03.812.004 / #lot 8932967 / applicator knob.Part 03.812.003 / #lot 8959887 / applicator inner shaft.Received the listed (3 ) parts in an assembled condition.The visual inspection has shown that the instruments are in almost brand new condition.There are no visible damages on the outside besides of some slight scratches, which most probably were caused by regular using.The device history records were researched and no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lots in question.The devices met the specifications at the time of manufacturing and distributing.Failure in materials or production could not be detected.Part 08.812.010s / lot # 9854764 / t-pal small, cage, height 10mm.The returned cage shows traces of nicks at some several points.We assume that the nicks were caused during surgery by trying to detach from the applicator shaft.Otherwise the rest of the implant is in good condition.The manufacturing document shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The device met the specifications at the time of manufacturing and distributing in march 2016.Failure in material or production could not be detected.Conclusion: the event description describes that during the surgery, the reported t-pal applicator inner shaft was not able to detach the reported t-pal cage after inserting and placing into the final position in the intervertebral disc space (l2-3).During investigation the reported complaint could not be reproduced.The returned cage could be inserted and detached with the applicator inner shaft without any effort as foreseen.The device passed successfully the performed functional test.Unfortunately we are not able to determine the exact cause of this complaint.It is likely that possibly improper handling or not exactly following according to technique guide could have impeded the detaching.In this regard and for more information.Because of no original fault we conclude that the cause of failure is not due to any manufacturing non-conformances.Synthes manufacturing location was discovered upon receipt of subject device.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 10MM X 28MM 10MM HEIGHT¿STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5635030
• MDR Text Key: 44551975
• Report Number: 2520274-2016-12568
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.812.010S
• Device Lot Number: 9854764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention