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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA 12 LONG R 130 L400 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA 12 LONG R 130 L400 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.270S
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 before inserting the nail, the scrub team tested the angle of the nail and found that the nail was bent. This event did not happen during a procedure. There was no patient impact. This report is for one (1) pfna ø12 long r 130° l400 tan. This is report 1 of 1 for complaint (b)(4).
 
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Brand NamePFNA 12 LONG R 130 L400 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key11952408
MDR Text Key280538332
Report Number8030965-2021-04643
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.270S
Device Lot Number64P4157
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device?

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