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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.053S
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is not available for reporting.Due to the intra-operative events,it is unknown if the device was successfully implanted.(b)(6).The (510k):unknown 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.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 europe reports an event in (b)(4) as follows: it was reported that a proximal femoral nail antirotion (pfna-ii) blade cannot lock during an unknown orthopaedic procedure on (b)(6) 2018.It is unknown if there was a surgical delay.Patient and surgical outcome is unknown.Concomitant device: unknown pfna-ii nail (part#unknown, lot#unknown, quantity#unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: corrected data: 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.Additional narrative: part: 04.027.053s, lot: l859632, manufacturing site: bettlach , release to warehouse date: 25.Apr.2018, expiry date: 01.Apr.2028.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Manufacturing investigation site: bettlach.Visual inspection: the device shows abraded color on both flanks of the body sleeve.The hexagon socket of the locking screw shows damage at the run-in.All these damages clearly were caused post-manufacturing as the anodized color on all damages was abraded.Functional test: the device passed successfully the performed functional test; the reported problem could not be reproduced.The blade could be locked and unlocked as foreseen.Conclusion: the complaint cannot be confirmed as the received condition of the complaint does not agree with the complaint description since the blade can be locked and unlocked as intended.The visible damage on socket of the locking screw let us conclude that the cause of failure is not due to any manufacturing non-conformances.We determine this complaint has be caused while inappropriate use.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.During the performed cq evaluation the root cause was identified as use related and therefore the in the investigation flow listed remaining investigation steps, document/specification review and dimensional inspection are not required.Additional data: 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 europe reports an event in singapore as follows: it was reported that during an open reduction internal fixation (orif) of left hip fracture on (b)(6) 2018, a proximal femoral nail antirotation (pfna-ii) blade could not lock.The surgeon stated that according to the pfna technique guide, upon turning the blade impactor clockwise to lock the blade, the gap should disappear after the blade is locked.However, there was a gap that remained even after fully tightening and locking the blade.A 95mm pfna blade was used to replace the 90mm pfna blade.The surgeon commented that usually for pfna, they will ensure the patient is put on non-weight bearing for two weeks.However, as they are afraid that the implanted blade will back out from the lateral cortex due to possible poor bone purchase after removal and insertion of a new blade, they decided to put the patient on non-weight bearing for four weeks.The procedure was completed successfully with a delay of 20-30 minutes.The patient was in stable condition.Concomitant device: pfna-ii nail (part: unknown, lot: unknown, quantity: unknown) this report is for a pfna-ii blade.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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review has been requested.Implant date, explant date: device malfunctioned intra-operatively and was not implanted / explanted.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)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7868506
MDR Text Key119956368
Report Number8030965-2018-56238
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,Followup
Report Date 08/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
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 NumberL859632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2018
Date Manufacturer Received11/06/2018
Patient Sequence Number1
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