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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SELZACH END-CAP F/A2FN CANN EXTENS. 0 TAN GREY ROD,FIXATION,INTRAMEDULLARY

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SYNTHES SELZACH END-CAP F/A2FN CANN EXTENS. 0 TAN GREY ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.009.000S
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Sedation (2368)
Event Date 09/20/2017
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight not available for reporting. (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 europe reports an event in (b)(6) as follows: it was reported on (b)(6) 2017 patient underwent a procedure to remove hardware implanted on an unknown date to treat a femoral diaphysis fracture. During the removal procedure, surgeon was not able to remove the end cap. It was decided to break the end cap using a carbide drill. Once completed, the end cap was removed safely using a removing tool. The area was washed thoroughly in order to remove any broken fragments. Intraoperative images verified no fragments were left in the patient. Surgery was completed with a delay of approximately three (3) hours. No adverse consequence to the patient was reported. Surgeon opinion was that the end cap may have been inserted diagonally with force or may have been tightened too much, causing the removal issue. Concomitant devices reported: carbide drill (quantity 1), removing tool (quantity 1). This report is for one (1) end cap for a2fn. This is report 1 of 1 for (b)(4).
 
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Brand NameEND-CAP F/A2FN CANN EXTENS. 0 TAN GREY
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ CH2545
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6948199
MDR Text Key89357225
Report Number3000270450-2017-10362
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.009.000S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
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