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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE; ROD, FIXATION, INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)
Patient Problem No Code Available (3191)
Event Date 07/30/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown nail head elements: pfna blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a synthes employee.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.(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 synthes reports an event in the (b)(6) as follows: it was reported that on (b)(6) 2020, a patient had a very hard bone due to cancer and during the insertion of the blade, the impactor would not fully rotate into its final position.The blade was unable to be locked into place and the impactor could not be removed.The surgeon attempted to hammer the blade into place.The surgeon was unable to advance the blade into its final locking position and the impactor would not release.The surgeon used the hammer to release the impactor.There was a surgical delay of twenty (20) to thirty (30) minutes.Patient outcome was unknown.Concomitant devices reported: impaction instruments: hammer/mallet: trauma (part number unknown, lot unknown, quantity 1), impactor f/pfna blade (part number 03.010.410, lot 515379, quantity 1).This report involves one (1) unknown nail head elements: pfna blade.This is report 2 of 2 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.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.H3, h4, h6: 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.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.
 
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Brand Name
UNK - NAIL HEAD ELEMENTS: PFNA BLADE
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10393152
MDR Text Key202558460
Report Number8030965-2020-05870
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received09/15/2020
Patient Sequence Number1
Treatment
IMPACTOR F/PFNA BLADE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA
Patient Outcome(s) Required Intervention;
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