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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION, INTRAMEDULLARY
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SYNTHES GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.053S
Device Problem Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent open reduction internal fixation surgery for a femoral trochanteric fracture.During the surgery, the blade couldn¿t be connected to the impactor.Another blade (95mm) and the same impactor were used, they connected to each other properly and the surgery was completed successfully with a 30 minute delay.Concomitant devices: unknown impactor (part# unknown, lot# unknown, quantity# 1).This report is for one (1) pfna blade.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: device history lot: part: 04.027.053s; lot: 56p7998; manufacturing site: bettlach; release to warehouse date: aug.06, 2020; expiry date: jan.05, 2030.A manufacturing record evaluation was performed for the finished device 04.027.053s, lot: 56p7998 and no non-conformances were identified.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 Name
PFNA-II BLADE L90 TAN
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10749829
MDR Text Key213505452
Report Number8030965-2020-08284
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,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.027.053S
Device Lot Number56P7998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2020
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/28/2020
Supplement Dates Manufacturer Received11/04/2020
11/18/2020
Supplement Dates FDA Received11/04/2020
12/04/2020
Patient Sequence Number1
Treatment
UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA
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