• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 80MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 80MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.380S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 05/02/2022
Event Type  Injury  
Event Description
Device report from synthes reports an event in switzerland as follows: cut-out of tfna helical blade.Nail was removed and replaced with a prosthesis.This complaint involves two (2) devices.This report is for one (1) tfna helical blade perf l80 tan.This is report 1 of 1 for complaint (b)(4).
 
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.Additional product code: hsb.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.
 
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.D2: additional procode: ktt h3, h4, h6: part: 04.038m380sp lot: 76p7092 part manufacturing date: 09 september 2020 manufacturing site: (b)(4) part expiration date: n/a nonconformance noted: n/a a review of the device history record revealed no complaint-related anomalies.The device history record shows lot 76p7092 of tfna fenestrated helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.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.A review of the raw material device history record(s) determined the raw material lot 14l0847 met all specifications with no issues documented that would contribute to this complaint condition.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device and received images.Visual analysis of the returned sample revealed that there was no damage or defects with the tfna helical blade perf l80 tan.However; was noted wear consistent with implantation and explantation and grinding marks were visible on the round and flat part of the shaft from helical blade.In addition, photos of the item were received as well and the x-ray images show the migration/backout.A dimensional inspection was performed for the tfna helical blade perf l80 tan and met specifications.A functional test was performed and the tfna helical blade was able to pass through the mating device (nail) hole/aperture without any issue.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the tfna helical blade perf l80 tan on the x-ray would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -ti tfna fenestrated helical blade dimensional inspection: feature: shaft diameter measured dimension: conforming.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TFNA FENESTRATED HELICAL BLADE 80MM - STERILE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14711460
MDR Text Key294946934
Report Number8030965-2022-04027
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819652552
UDI-Public(01)07611819652552
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.038.380S
Device Lot Number76P7092
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2022
Initial Date FDA Received06/16/2022
Supplement Dates Manufacturer Received07/18/2022
07/25/2022
Supplement Dates FDA Received07/20/2022
08/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2020
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
TFNA FEM NAIL Ø11 125° L200 TIMO15.
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient SexFemale
-
-