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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS BLADE Ø12.5 L65 TAN; ROD, FIXATION, INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH DHS BLADE Ø12.5 L65 TAN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.224.065S
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent osteosynthesis surgery for femoral subtrochanteric fracture.During the surgery, when the surgeon opened the blade (65mm) package, the blade was already locked, and he couldn¿t unlock the blade.The surgeon used another blade (70mm) instead, and the surgery was completed successfully with less than 30 minutes delay.No further information is available.This complaint involves one (1) device.This report is 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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.Investigation site: cq zuchwil, selected flow: device interaction/functional.Visual inspection the blade was received in a unlocked condition.The blade did rotate freely.The overall appearance of the device is in a good condition.No other visual damage could be observed at the blade.All features related to the reported complaint condition were reviewed and no other issues were identified.Functional test: functional test is not appropriate, as the blade did rotate freely and no functional deviation was found.However, functional test was performed per 100% at the time of manufacturing with no non-conformities documented.Dimensional inspection: all the documents have been reviewed with the result that no product design or manufacturing issues were observed that may have contributed to the complaint condition.Summary: the complaint is not confirmed as the received blade is functional as required.The for the complaint relevant dimensions were checked as far as possible and found to be within specifications.Unfortunately, the instruments which were used during the surgery were not returned, therefore the root cause of the complained malfunction cannot be defined as it was not possible to replicate the occurrence with the received blade.However, since no fault could be found in material or during the production procedures, it is likely that a handling issue has lead to the complained malfunction.Finally we conclude that the cause of failure is not due to any manufacturing non-conformances.During the investigation, no manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part: 04.224.065s, lot: 4l15131, manufacturing site: grenchen, release to warehouse date: apr.19, 2019, expiry date: apr.01, 2029.A manufacturing record evaluation was performed for the finished device lot number, 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
DHS BLADE Ø12.5 L65 TAN
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9578478
MDR Text Key189170396
Report Number8030965-2020-00269
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819795457
UDI-Public(01)07611819795457
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 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.224.065S
Device Lot Number4L15131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Date Manufacturer Received02/13/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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