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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 135MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 135MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT Back to Search Results
Catalog Number 413.035
Device Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/20/2018
Event Type  malfunction  
Manufacturer Narrative
Patient height is reported as 175cm.Patient identifier is unknown.Additional procode: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter phone number is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.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 europe reports an event in (b)(6) as follows: it was reported that (b)(6) 2018, patient underwent removal of hardware.The surgeon had cut the titanium plates in order to remove them, because of a defective screw thread on the two (2) screws.The hardware was originally implanted on (b)(6) 2018, to treat a closed fracture of the tibia's diaphysis by a reduction and an osteosynthesis with tibial and fibular plates.Surgery was completed successfully with a delay of two-hour delay.The patient's condition is stable; he is being treated with antibiotherapy for an osteoarticular infection.This report is for a 3.5mm titanium (ti) locking screw self-tapping 35mm.This is report 2 of 2 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 evaluated by mfr: part: 413.035; lot: l744264; manufacturing site: grenchen; release to warehouse date: january 17, 2018.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation selection investigation site: cq zuchwil; selected flow: 2.Device interaction/ functional visual inspection: the complained screw is still blocked in the plate.There are mechanical damages on entire part's surface.Furthermore, the screw recess is badly damaged.Dimensional inspection: as the screw is still blocked in the counterpart, the relevant features were not able to be measured.Document/ specification review: as indicated in the manufacturing documents, this lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Material review: not required per selected investigation flow as root cause is use related.Summary: our investigation has shown that the complaint condition is confirmed, as the screw is still blocked into the plate.We are not able to determine the exact cause of this occurrence.Multiple factors can lead to technical difficulties during removal of plates with screws.These factors include but are not limited to: wrong torque or angulation of the screw during insertion leading to cold-welding between the plate and the screw thread.Since not all of them can be investigated and excluded from the root cause analysis, no final statement about the cause of such issues can be made.Based on the investigation results we conclude that the cause of failure is not due to any manufacturing non-conformances.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.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
The infection occurred after the first surgery on (b)(6) 2018.This infection and the resulting scar flow are the cause of the revision surgery on (b)(6) 2018.
 
Event Description
It was further reported that the two plates were not defective.The two plates were voluntarily cut because the 2 screws were defective.The surgeon cut the external and internal plates with a cut-broch clamp.The removal of the internal plate was more complex and longer than the removal of the external plate.All fragments were removed from the patient.
 
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.
 
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Brand Name
3.5MM TI LOCKING SCREW SELF-TAPPING 135MM
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7797865
MDR Text Key117614871
Report Number8030965-2018-55820
Device Sequence Number1
Product Code KTW
UDI-Device Identifier07611819239289
UDI-Public(01)07611819239289
Combination Product (y/n)N
PMA/PMN Number
K011815
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 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number413.035
Device Lot NumberL744264
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2018
Date Manufacturer Received09/19/2018
Patient Sequence Number1
Patient Age36 YR
Patient Weight70
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