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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TITANIUM END CAP FOR TITANIUM ELASTIC NAILS 1.5-2.5MM ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH TITANIUM END CAP FOR TITANIUM ELASTIC NAILS 1.5-2.5MM ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 475.905
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. Product was not returned. Based on the information available, it has been determined that no corrective and 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), the patient suffered from erythema and inflammation on the skin near the device which was used for treating right fibula fracture in an unknown surgery on (b)(6) 2021. Immediate use of anti-swelling medication, continued observation and treatment were given to the patient. No additional information could be provided. This complaint involves two (2) devices. This report is for (1) titanium end cap for titanium elastic nails ø1. 5-2. 5mm. This report is 2 of 2 (b)(4).
 
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Brand NameTITANIUM END CAP FOR TITANIUM ELASTIC NAILS 1.5-2.5MM
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11724631
MDR Text Key247303492
Report Number8030965-2021-03258
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K082148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number475.905
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 Received03/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/26/2021 Patient Sequence Number: 1
Treatment
TEN Ø2.5 L440 TAN PINK
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