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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT; PLATE, FIXATION, BONE

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SYNTHES GMBH 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.124.220
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Synthes lot # 18p2758.Supplier lot # n/a.Supplier batch # 10l3218.Release to warehouse date: 10oct2019.Supplier: jabil-monument.No ncr's were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Complaint is confirmed as we are able to confirm complaint description, as it is visible that one plate has 16 holes instead of 14, based on the received pictures.Jabil nonconformance will investigate this complaint.The root cause was traced to manufacturing error.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 on an unknown date that the locking compression plate (lcp) was shorter than the normal size.It was not used in a procedure.This report is for one (1) 3.5mm ti lcp proximal tibia pl low bend 14 holes/206mm/right.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device has been 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h3, h4, h6: part 04.124.220, lot 18p2758: release to warehouse date: october 10, 2019.Supplier: (b)(4).No non-conformance reports (ncr's) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: complaint is confirmed as we are able to confirm complaint description, as it is visible that one plate has 16 holes instead of 14, based on the received pictures.The root cause was traced to manufacturing error.Relevant actions have been taken to address the issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11261041
MDR Text Key230243924
Report Number8030965-2021-00758
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K030597
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 01/12/2021
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 Number04.124.220
Device Lot Number18P2758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Initial Date Manufacturer Received 01/12/2021
Initial Date FDA Received02/01/2021
Supplement Dates Manufacturer Received03/01/2021
03/16/2021
Supplement Dates FDA Received03/01/2021
04/01/2021
Patient Sequence Number1
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