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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER; ROD,FIXATION,INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.033.003
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed.Product was not returned.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) 2020, the cam lock lever from the radiolucent aiming arm snapped off as the surgeon was post insertion of recon screws.The cam lock lever broke into two pieces, and both parts were retrieved easily without additional intervention.There was no surgical delay.There was no patient consequence.The procedure was successfully completed.Concomitant device reported: unk; screws: trauma (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) radiolucent aiming arm/frn greater trochanter.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.Investigation summary investigation site: cq zuchwil, selected flow: damage / broken.The returned device 03.033.003 bearing lot no.L836625, is the complete radiolucent aiming arm.The broken component 03.010.497 bearing lot no.T165411 (from sub-component 60077325) is the cam lock lever, which was built in, is broken.Visual inspection: the visual inspection has shown that one cam lock lever has broken off from the radiolucent aiming arm.The cam lock lever was broken into two portion and was returned for evaluation.On the second cam lock lever there were no defects identified.Furthermore, the pins which hold the cam lock levers shows some deformations/damages.Otherwise the device is in a good condition.Dimensional inspection: since the component 03.010.497 has been broken off, a dimensional inspection cannot be carried out according to then valid drawing.However, the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Document / specification review: drawing (cam lock lever) were reviewed during this investigation.The complete device was manufactured in may 2018 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.One cam lock lever was found broken into two portions.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.This lot was manufactured in may 2018.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.While no definitive root cause could be determined it is possible that the device encountered unintended forces.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: 03.033.003, lot: l836625, manufacturing site: hägendorf, release to warehouse date: may 2, 2018.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.
 
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.
 
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Brand Name
RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10830839
MDR Text Key216139259
Report Number8030965-2020-08899
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07612334121790
UDI-Public(01)07612334121790
Combination Product (y/n)N
PMA/PMN Number
K172157
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 10/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.033.003
Device Lot NumberL836625
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2020
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PROTECT SLEEVE 11.5/8.5 F/LFN RECOLOCK; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
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