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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/32MM; CERCLAGE, FIXATION
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OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/32MM; CERCLAGE, FIXATION Back to Search Results
Catalog Number 42.231.232
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Unknown event date is 2020.Pma/510k: this report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 a revision procedure occurred on (b)(6) 2020 due to device migration.The plate remains implanted while three screws were explanted.The original surgery occurred on (b)(6) 2020.The patient received a variable angle (va) condylar plate for a distial femur fracture.It was determined on (b)(6) 2020 it was determined by x-ray that the three screws migrated from the plate.The patient was revised to three new screws and the construct will be will routinely removed in (b)(6) 2020.Concomitant devices reported: va-lcp condylar plate 4.5/5.0 r 6ho l159 (part# 04.124.406, lot# unknown, quantity# 1).This is report 1 of 3 for (b)(4).This report is for an unknown screw.
 
Event Description
Update to event description: there was no reported surgical delay.Revision surgery was completed successfully.This report is for a 5.0mm val screw/optilink(tm) slf-tpng/strdrv/32mm.
 
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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
 
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 summary: investigation selection investigation site: customer quality (cq) zuchwil.Selected flow(s): device interaction/functional and damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: upon visual inspection of the complaint device it can be seen that the thread at the screw head and also at the neck section are deformed in manner which resulted from contact to a hard material, most likely metallic instrument as pliers.In addition, the screw is in a used but otherwise in a good condition, as the shank and tip section is no damage showing.Functional test: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no functional test is needed.Furthermore, a functional test is not possible, as the relevant features are deformed in a manner which prevents accurate functional test.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Document/specification review: drawings and revisions are in accordance to dhr of production lot l458798.All relevant features are defined on the used drawing revisions of dhr of production lot l458798.Summary: the review of the production history revealed that this item was manufactured in august 2017 according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.Unfortunately, we are not able to determine the exact reason for this occurrence.The complaint is rated as confirmed, but not valid from manufacturing point of view, as the investigations performed didn¿t identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.Furthermore, we are not able to confirm the reported incident (backout/migration), but the deformation could have had an influence on the reported issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 42.231.232, lot: l458798, manufacturing site: mezzovico, release to warehouse date: aug 22, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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
5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/32MM
Type of Device
CERCLAGE, FIXATION
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10194593
MDR Text Key199982365
Report Number8030965-2020-04415
Device Sequence Number1
Product Code JDQ
Combination Product (y/n)N
PMA/PMN Number
K162124
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 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number42.231.232
Device Lot NumberL458798
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2020
Date Manufacturer Received08/21/2020
Patient Sequence Number1
Treatment
UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; VA-LCP CONDYLAR PLATE 4.5/5.0 R 6HO L159
Patient Outcome(s) Required Intervention;
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