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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA Ø9 LONG R 130° L300 TAN; ROD, FIXATION, INTRAMEDULLARY

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SYNTHES BETTLACH PFNA Ø9 LONG R 130° L300 TAN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.023.104S
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Date 10/19/2016
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: additional product code: hwc.Device is not distributed in the united states, but is similar to device marketed in the usa (b)(4).Device broke intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.The pfna nail broke postoperatively and will require additional surgical intervention to remove the construct.The 510k #unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 on an event in (b)(6) as follows: it was reported that a proximal femoral nail antirotation (pfna) broke postoperatively.Complaint involves 1 part.This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
(b)(4).Is this a single use device that was reprocessed and reused on a pt?, device available for evaluation? (b)(6).Device history records review was completed for part # 04.023.104s, lot # 9785529.Manufacturing location: (b)(4), manufacturing date: jan 26, 2016.Expiry date: jan 01, 2026.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Corrected data: date of event is unknown.Implant date, explant date.Reporter country.Device 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
Post-operative x-ray also revealed broken locking bolt.Patient outcome is not reported.This is report 1 of 2 for (b)(4).
 
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Brand Name
PFNA Ø9 LONG R 130° L300 TAN
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ  CH2544
Manufacturer (Section G)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ   CH2544
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6068106
MDR Text Key58813767
Report Number9612488-2016-10438
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.023.104S
Device Lot Number9785529
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2016
Initial Date FDA Received10/31/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2016
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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