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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH EXPERT A2FN NAIL Ø13 R CANN L420 TAN LIG ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH EXPERT A2FN NAIL Ø13 R CANN L420 TAN LIG ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.009.664S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/25/2022
Event Type  Injury  
Manufacturer Narrative
This report is 1 of 7 for (b)(4). 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.
 
Event Description
A2fn removed from patient after complaints of pain. Implant removed successfully.
 
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Brand NameEXPERT A2FN NAIL Ø13 R CANN L420 TAN LIG
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14166856
MDR Text Key289741921
Report Number8030965-2022-02590
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
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 Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.009.664S
Device Lot Number3703017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2022 Patient Sequence Number: 1
Treatment
END-CAP F/A2FN CANN EXTENS. 10 TAN GREY; EXPERT A2FN NAIL Ø13 R CANN L420 TAN LIG; LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L50 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L58 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L76 F/NAILS TAN LIGHT GREEN
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