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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW, FIXATION, BONE Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 that following a second surgical intervention on (b)(6) 2019 (osteosynthesis was performed with an anatomical clavicle plate) an infection at the site of the osteosynthesis material appeared and made the material loose again.Dr.(b)(6) decided to remove the material, wash, debride and close.In the institution they send the material to an internal process called sonication, it is not returned or sent to quality.This complaint involves fourteen (14) devices.This is 9 of 9 for report (b)(4).
 
Event Description
Originally, the patient underwent an osteosynthesis of a sternoclavicular dislocation with a blocked sternum system, on (b)(6) 2019, the surgeon decided to place the emergency rod upside down, as surgeon found the other way to be not comfortable.It is explained that the system is indicated for sternum closure and that rod blocks and secures the plate.But the system failed and the patient was reoperated after 8 days ((b)(6) 2019), an anatomical clavicle plate with lateral extension was used at each side, from the sternum to the clavicle.Surgeon accepted that it was his decision to turn the emergency rod and the system has failed for that reason.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.D6a.D6b: explantation date is unknown.
 
Event Description
It was reported that on (b)(6) 2019, the patient diagnosed with a bilateral sternoclavicular dislocation underwent an osteosynthesis with a sternum plate, the surgeon decided on that occasion to place the plate safety hook upside down, which caused the system to loosen.On (b)(6) 2019, this osteosynthesis material was removed at the institution, and the sternoclavicular dislocation fixation was performed again bilateral with anatomical bilateral clavicle plate.This material failed again, became infected and loosened.The surgeon decided to remove the material, wash, debride and close.Finally, on (b)(6) 2020, the patient is reoperated again to do anatomical reduction with an x-shaped polyester suture.This report captures the second event of material loosening and infection while related (b)(4) captures the first event of sternal plate loosening.
 
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
Additional event information.This report was clarified that this report was reported since 2019 and this is the fourth reintervention of the patient since that date, the first report has already been had closed.On (b)(6) 2019, the patient diagnosed with a bilateral sternoclavicular dislocation underwent an osteosynthesis with a sternum plate, the surgeon decided on that occasion to place the plate safety hook upside down, which caused the system to loosen.On (b)(6) 2019, this osteosynthesis material was removed at the institution, the sternoclavicular dislocation fixation was performed again bilateral with bilateral clavicle anatomical plate, this material again failed, became infected and loosened, the surgeon decided to remove the material, wash, debride and close.Finally, on (b)(6) 2020, the patient is reoperated again.The surgeon decides to do anatomical reduction with an x-shaped polyester suture, the procedure was performed in the company of the institution's thorax surgeon.
 
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Brand Name
UNK - SCREWS: TRAUMA
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9251780
MDR Text Key179515515
Report Number8030965-2019-69765
Device Sequence Number1
Product Code HWC
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,Followup
Report Date 10/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
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 Received01/14/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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