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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.016.240S
Device Problems Break (1069); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the multiloc peg was introduced with the applicator in an attempt to lock, but the locking holes were found to be misaligned. The surgeon removed the nail and observed that it was damaged at the zone of the tip connection of insertion handle. The implant was changed for a new one. Procedure was completed successfully with a delay of ten minutes. There was no patient consequence. This report is for a 7mm titanium (ti) multiloc humeral nail. This is report 1 of 1 for (b)(4).
 
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Brand Name7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12481010
MDR Text Key271681020
Report Number8030965-2021-07782
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K120807
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,Followup,Followup,Followup,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.240S
Device Lot Number52P5531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

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