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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.9MM LOCKING BOLT 38MM; PIN, FIXATION, THREADED
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OBERDORF SYNTHES PRODUKTIONS GMBH 4.9MM LOCKING BOLT 38MM; PIN, FIXATION, THREADED Back to Search Results
Catalog Number 259.380
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
Additional procodes: jds, hsb.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported on (b)(6) 2019, the patient underwent removal of osteosynthesis material, with graft taking as well as osteosynthesis of the femur due to broken nail and pseudoarthrosis of the right femur.A universal femoral nail was removed, along with a 38mm locking bolt, a 40mm locking bolt, and a 42mm locking bolt.The universal femoral nail was broken above the fracture site during the procedure, so that it could be extracted completely.There are three (3) pieces of nails left.Initially, the patient underwent open reduction and osteosynthesis fracture (orif) of the right femur on (b)(6) 2013, with a universal femoral nail, two (2) locking bolts, and two (2) proximal locking bolts.Procedure outcome and patient status are unknown.This report is for a 4.9mm locking bolt 38mm.This is report 2 of 5 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.A review of the device history records has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Lot provided for reporting.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.A review of the device history record part: 259.380.Lot: 8233479.Manufacturing site: grenchen.Release to warehouse date: 20 december 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The device was received, it was reported on march 9, 2019, the patient underwent removal of osteosynthesis material, with graft taking and osteosynthesis of the femur due to rx broken nail and pseudoarthrosis of the right femur.Initially, the patient underwent open reduction and osteosynthesis fracture of right femur on (b)(6) 2013, with universal femoral nail, two (2) locking bolts, and two (2) proximal locking bolts, curettage right femur and washing.The universal femoral nail was removed along with 38mm locking bolt, 40mm locking bolt, and 42mm locking bolt.The universal femoral nail was broken above the fracture site but in surgery, so that it could be extracted completely.There are three (3) pieces of nails left.It was unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Flow: visual(appearance not as expected).Visual inspection: received device was received in stripped and worn condition.Received condition agrees with complaint condition.Document reviews: relevant drawings for the returned device (both current revision and from the time of manufacture).Conclusion: while no root cause could be determined it is likely that the age of the device (approximately 7 years) with consistent usage could have contributed to this worn condition which in turn contributed to complaint condition.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.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
4.9MM LOCKING BOLT 38MM
Type of Device
PIN, FIXATION, THREADED
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8483614
MDR Text Key140931098
Report Number8030965-2019-62493
Device Sequence Number1
Product Code JDW
UDI-Device Identifier07611819010369
UDI-Public(01)07611819010369
Combination Product (y/n)N
PMA/PMN Number
K970097
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 03/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number259.380
Device Lot Number8233479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2019
Date Manufacturer Received05/13/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age32 YR
Patient Weight63
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