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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT; TEMPLATE
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OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT; TEMPLATE Back to Search Results
Catalog Number 03.812.511
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device is not distributed in the united states but is similar to device marketed in the usa.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 reports an event in (b)(6) as follows: it was reported on an unknown date that the tpal inserter was broken during inserting the trial cage with the hammer.Also uses the new inserter for the tpal.It was happened twice before the new inserter.It breaks on the top of knob.The surgery was delayed 20-30 mins.The patient outcome was unknown.Concomitant device reported: unknown hammer ( part# unknown, lot# unknown, quantity 1), applicator knob ( part# 03.812.004, lot# unknown, quantity 1), advance applicator outer shaft ( part# 03.812.520, lot# unknown, quantity 1).This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Concomitant device: advance applicator inner shaft ( part# 03.812.521, lot# unknown, quantity 1).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation site: cq zuchwil selected flow: damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the cap at the end of the shaft is broken off as complained, the cap was returned for evaluation.In general is the inner shaft in a used condition, there are clearly visible wear marks at the trail implant, especially the medial orientated edges, where the surficial contact should prevent rotation in tightened position are strongly worn.Dimensional inspection: the relevant dimension at the fracture face cannot be verified anymore as the breakage occurred at the crossover of the cut in.In addition it looks like the surface is deformed in this area due to very high torsional forces before the breakage.Drawing/specification review: the fork shaft sub-component 60051594 is not lot tracked.Therefore the last three potential work orders (15192590, 15310911 and 15310914) that were produced prior to lot l220352 were reviewed.The review has shown that with 1.4028 stainless steel the correct material was used and that the hardness was within the specification.Investigation conclusion: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.This lot of 12 pieces was manufactured in december 2016 and we are not aware of any other complaint for this article- and lot combination.This, the used condition of the trail implant and the appearance of the broken cap of the device speaks against a manufacturing related issue.The fracture face has the typical view of a by torsional forces caused forced rupture.Next to the fracture face of the cap are very strong torsional stress marks visible.Based on that we have to assume that the device was for any reason exposed to inappropriate torsional forces which did lead to a mechanical overload and finally the breakage of the cap.In general it can be stated that the t-pal applicator instruments are designed and produced to withstand normal forces during a surgery.As every surgeon has a different tactile feeling/feedback and forces can vary, the inner shaft has a predetermined breaking point on the proximal end.Whenever a certain axial force is being achieved the instrument should break rather on the proximal end than on the distal end.This allows the surgeon to dismantle the instrument and remove it safely with no patient contact to any broken parts.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part: 03.812.511, lot: l220352 , manufacturing site: hägendorf, release to warehouse date: dec.14, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.
 
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Brand Name
T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT
Type of Device
TEMPLATE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9513045
MDR Text Key194100197
Report Number8030965-2019-71391
Device Sequence Number1
Product Code HWT
UDI-Device Identifier07611819420724
UDI-Public(01)07611819420724
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/03/2019
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 Number03.812.511
Device Lot NumberL220352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Initial Date Manufacturer Received 12/03/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received01/15/2020
02/06/2020
Supplement Dates FDA Received02/06/2020
02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADVANCED APPL INNER SHAFT; ADVANCED APPL OUTER SHAFT; APPLICATOR KNOB; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE
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