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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS; ROD, FIXATION, INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 10/26/2019
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown nail.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial 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 (b)(6) as follows: it was reported during a hip fracture with tumor removal surgery on (b)(6) 2019, the surgeon placed a nail diameter 11 (it was indicated to be 10), introduced the nail, and when he decided to remove it, it could no longer be done; in this process of attempting the withdrawal, the impactor broke, leaving in the insertion arch a fragment.The surgery was completed successfully, no fragment was left in patient.There was a delay of 10-15 minutes.He was able to remove the tumor located in the upper area of the neck of the femur, the surgeon mentions that he does not need to block the nail with the distal screw.Concomitant device reported: unknown insertion handle (part# unknown, lot# unknown, quantity# 1), unknown hammer/mallet (part# unknown, lot# unknown, quantity#1).This is 2 of 2 for report (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.
 
Event Description
Concomitant device reported: hybrid insertion handle (part# 03.037.011, lot# 9881139, quantity# 1) unknown hammer/mallet (part# unknown, lot# unknown, quantity#1).
 
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 - NAILS
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9369413
MDR Text Key185673264
Report Number8030965-2019-70551
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 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
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 Received12/18/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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