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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 03.019.007
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Manufacturer Narrative
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. 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 on (b)(6), 2021, the patient underwent open reduction internal fixation surgery for surgical neck fracture of the humerus. Before the surgery, when the sales rep explained about the drill sleeve to a nurse, something like a blood clot came out of the drill sleeve. The drill sleeve was cleansed and re-sterilized. During the surgery, when the surgeon inserted a nail using a guide rod and passing the connecting screw into the nail, a blood clot came flying. The guide rod in the unclean area was cut, the connecting screw was removed, and the connecting screw was cleansed and sterilized again. The surgeon took advantage of the time that connecting screw was being re-sterilized to remove the ilium. However, the time for re-sterilization took longer than that, so there was a time when the procedure could not be proceeded. The surgery was completed within thirty (30) minutes delay. It is possible that this event was caused by an insufficient cleansing at another hospital that used the same products before. No further information is available. This report is for one (1) connecting screw/cannulated for multiloc humeral nail. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameCONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13179731
MDR Text Key289266782
Report Number8030965-2022-00158
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
Treatment
DRILLSL 10/3.8 F/03.019.013; UNK - NAILS: HUMERAL; UNK - SCREWS: TRAUMA; UNK- GUIDE ROD
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