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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.019.270S
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, that while impacting the hn multiloc ø 8 nail in the proximal part, it was damaged and bent in the part where it connects to the aiming arm. It was decided to change it for the hn multiloc ø 7 nail. When the assistant opened the sealed box, it came with the metal packaging open, so factory sterility was no longer guaranteed. Due to this setback and due to the urgency of the specialist to go out for another procedure, the patient was not fitted with any device for fixation, so this weekend a second surgery is planned to perform the osteosynthesis. This report involves one (1) 8. 5mm ti multiloc humeral nail left/cann/270mm-sterile. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
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Brand Name8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13740374
MDR Text Key289333401
Report Number8030965-2022-01568
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K120807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.019.270S
Device Catalogue Number04.019.270S
Device Lot Number98P5935
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/11/2022 Patient Sequence Number: 1
Treatment
MULTILOC HN Ø8.5 LE CANN L270; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA
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