Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY
  • 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 11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.144S
Device Problems Break (1069); Device-Device Incompatibility (2919)
Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: event year is reported as 2020; however exact date of event is unknown.Reporter is jnj representative.The investigation could not be completed, no product was received; 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 on (b)(6) 2020, the patient was treated with a tfna set.After the procedure, it was notice that the femoral neck component moved out laterally even though it was locked statically.The patient condition was unknown.Concomitant device reported: tfna end cap (part # 04.038.000s, lot # 50p9709, quantity 1), locking screw (part # 04.005.524, lot # 33p8476, quantity 1).This complaint involves two (2) devices.This report is for (1) 11mm/130 deg ti cann tfna 235mm/right - sterile.(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 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: manufacturing location: monument, manufacturing date: january 13, 2020, expiration date: december 1, 2029, part number: 04.037.144s, 11mm/130 deg ti cann tfna 235mm/right-sterile, lot number: 34p5783 (sterile), lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, n071293 rev e met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and all components issued met current defined requirements.Scn supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿component moved out laterally even though it was locked statically¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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
11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10855878
MDR Text Key217161532
Report Number8030965-2020-08998
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819650527
UDI-Public(01)07611819650527
Combination Product (y/n)N
PMA/PMN Number
K160167
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 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.037.144S
Device Lot Number34P5783
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2020
Patient Sequence Number1
Treatment
LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN
Patient Outcome(s) Required Intervention;
-
-