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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH EXPERT A2FN Ø11 R CANN L420 TAN LIGHT GR ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH EXPERT A2FN Ø11 R CANN L420 TAN LIGHT GR ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.009.464
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. (nail damage) couldn't be verified. Product was not returned therefore no further investigation possible. 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 (information or/and material), the investigation will be updated as applicable. A device history record (dhr) review was conducted: part: 04. 009. 464s, lot: l902819, manufacturing site: (b)(4), release to warehouse date: 18. June 2018, expiry date: 01. June 2028. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. 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)india as follows: it was reported that during an unknown procedure on an unknown date in 2020, an expert a2fn nail was stuck in femoral canal. Surgeon used nail extractor to remove the nail, however in the process of removal the nail got damaged/cracked. Another nail was used to finish the case. There was a surgical delay of thirty (30) minutes due to the reported event. Procedure was successfully completed. Patient outcome is reported as stable. Concomitant device reported: nail extractor(part # 03. 010. 373, lot # unknown, quantity 1). This report is for one (1) expert a2fn ø11 r cann l420 tan light gr. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameEXPERT A2FN Ø11 R CANN L420 TAN LIGHT GR
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10968621
MDR Text Key220238586
Report Number8030965-2020-09498
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.009.464
Device Lot NumberL902819
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2018
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/08/2020 Patient Sequence Number: 1
Treatment
NAIL EXTRACTOR
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