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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH END-CAP F/A2FN CANN EXTENS. 10 TAN GREY ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH END-CAP F/A2FN CANN EXTENS. 10 TAN GREY ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.009.002S
Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that in (b)(6) 2020, the patient underwent surgery for femoral shaft fracture with afnj implants at another hospital. After surgery, on (b)(6) 2021, revision surgery for removing implants was performed. In the revision surgery, it was found that the endcap had not been inserted fully. There seemed to be a high possibility that the threaded part on the nail had been broken. The surgery was completed with 60 minutes delay. The health hazard due to this event is prolongation of operation time and expansion of incision. The patient outcome is stable. Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity 1). This complaint involves two (2) devices. This report is for (1) end-cap f/a2fn cann extens. 10 tan grey. This is report 3 of 3 or complaint (b)(4).
 
Manufacturer Narrative
(b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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 NameEND-CAP F/A2FN CANN EXTENS. 10 TAN GREY
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key12960405
MDR Text Key281915566
Report Number8030965-2021-10029
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.009.002S
Device Lot Number25P3179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2019
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/08/2021 Patient Sequence Number: 1
Treatment
EXPERT A2FN NAIL Ø9 R CANN L340 TAN LIGHT.; UNK - SCREWS: TRAUMA.
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