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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PROTECT SLEEVE 16/11 F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PROTECT SLEEVE 16/11 F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 356.818
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation with the protection sleeve for the fracture of the trochanteric femur. During inserting the pfna blade, the surgeon did not recognize the key was attached to the blade and insert the blade with the hammer without matching the shape. The blade was stuck in the protection sleeve, so that the surgeon used another blade. The surgery was completed successfully. It was reported that it was caused by insufficient attention of the assistant doctor in the situation where the resident was using it for the first time. No further information is available. This report is for one (1) protect sleeve 16/11 f/pfna blade. This is report 1 of 2 for (b)(4).
 
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Brand NamePROTECT SLEEVE 16/11 F/PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13731730
MDR Text Key287002958
Report Number8030965-2022-01521
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 Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number356.818
Device Lot Number2257463
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

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