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: OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN ¿ 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
 

OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN ¿ STERILE; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.000S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: device remained implanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.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 europe reports an event in (b)(6) as follows: it was reported that orif (open reduction internal fixation) was applied to femoral trochanteric fractures on (b)(6) 2018.During the surgery, the surgeon could not tighten the end cap (0mm in size).He used another end cap (5mm in size) and he could tighten it.However, he was concerned about adverse event (pain, etc) due to bigger size, so he put the end cap (0mm in size) back in place.The end cap did not fit to a nail properly.The surgery was completed within 30-minutes delay.There was no adverse consequence to the patient.Surgery was completed successfully with patient in stable condition.Concomitant device reported: nail (part# unknown, lot# unknown, quantity 1).This report is for one (1) ti end cap for tfna 0mm extn ¿ 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.Part: 04.038.000s; lot: l716787; manufacturing location: (b)(4); release to warehouse date: january 16, 2018; expiry date: january 01, 2028; no nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.Corrected data: date received by manufacturer for mfr report#: is june 22, 2018.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
TI END CAP FOR TFNA 0MM EXTN ¿ STERILE
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7595604
MDR Text Key110862440
Report Number8030965-2018-54300
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819648708
UDI-Public(01)07611819648708
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
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.038.000S
Device Lot NumberL716787
Was Device Available for Evaluation? No
Date Manufacturer Received07/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-