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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/RT-STER; PLATE, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/RT-STER; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.118.012S
Device Problems Device-Device Incompatibility (2919); Device Difficult to Maintain (3134); Device Handling Problem (3265)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 10/07/2019
Event Type  Injury  
Manufacturer Narrative
Additional procode: hwc.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported that during removal 2.7 variable angle (va) screws from the va ankle system on (b)(6) 2019, the screws were broken.Additionally, during the procedure, the stardrive recess wasn't working.Procedure status and patient outcome are unknown.Concomitant devices: cortscr ø3.5 self-tap l36 sst (part: 02.200.03, lot: h192334, quantity: 1), cortscr ø3.5 self-tap l40 sst (part: 02.200.040, lot: h184231, quantity: 1), locking screws (part: unknown, lot: unknown, quantity: 1).This report is for a 2.7/ 3.5mm va locking compression plate (lcp) medial distal tibia plate.This is report 4 of 6 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.Visual inspection: upon visual inspection of the complaint device it can be seen that the implant has scratches, dents and deformation all over the part from use, this thus confirming the complaint description.In addition, two (2) va-locking-holes are badly damaged.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.Furthermore the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage.Document/specification review: drawings and revisions are in accordance to dhr of production lot 9398549.All relevant features are defined on the used drawing revisions of dhr of production lot 9398549.Summary: as the va-locking-holes are drilled out, and as we haven¿t received the screws or the screwdriver, we are not able to reproduce this incident.Unfortunately, we are not able to determine the exact reason for this occurrence, but we assume that the screws could have been blocked in the plate or that the recess at the screw had was damaged.The cause of complained malfunction is a post-manufacturing caused and/or use related, therefore the in the investigation flow listed remaining investigation steps are not required.Based on this the complaint is rated as non-confirmed, and not valid from the manufacturing point of view.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history: part: 02.118.012s.Lot: 9398549.Manufacturing site: raron.Release to warehouse date: 19.Mar.2015.Expiry date: 01.Mar.2025.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.
 
Manufacturer Narrative
Product complaint # (b)(4).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.
 
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
2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/RT-STER
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9304260
MDR Text Key185014532
Report Number8030965-2019-70154
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819515451
UDI-Public(01)07611819515451
Combination Product (y/n)N
PMA/PMN Number
K120854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02.118.012S
Device Lot Number9398549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2019
Date Manufacturer Received01/14/2020
Patient Sequence Number1
Treatment
CORTSCR Ø3.5 SELF-TAP L36 SST; CORTSCR Ø3.5 SELF-TAP L40 SST; UNK - SCREWS: LOCKING
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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