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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HYBRID INSERTION HANDLE; ROD,FIXATION,INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH HYBRID INSERTION HANDLE; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.011
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during sales training it was identified that external thread of the driving cap was damaged and internal thread of the insertion handle was possibly damaged.There is no patient involvement reported.This report is for one (1) hybrid insertion handle.This is report 2 of 2 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, h4, h6 investigation summary visual inspection: the visual inspection confirmed that the first two threaded pitches of insertion handle are damaged.The instrument is in a used condition wear and tear marks at the connection part of nail visible as well at the connection surface at the driving cap.Dimensional inspection: the relevant dimensions cannot be verified due to the damage incurred.Document/specification review: drawing was reviewed during this investigation.The returned insertion handle was manufactured in september 2017 according to the specifications.This lot passed all inspection steps during manufacturing without any deviations and was function checked per 100%.Summary: the returned insertion handle was examined and the complaint condition was able to be confirmed.The investigation has shown that the first two threaded pitches of the mentioned instrument are damaged.Based on this findings of the returned parts (driving cap and insertion handle) we conclude that the cause of failure is not due to any manufacturing non-conformances.We assume that the thread pitches of the insertion handle was damaged by a loose or insufficient tightening between the driving cap and insertion handle during the nail insertion.Such a loose connection, in combination with high vertical stress of the driving cap, can lead to such a damage of the threaded pitches of the insertion handle.This production lot (l425511) was manufactured in september 2017 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would have contributed to this complaint condition.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 part number: 03.037.110, lot number: l425511, manufacturing site: hägendorf, release to warehouse date: 29.Sep.2017.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
HYBRID INSERTION HANDLE
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10048155
MDR Text Key190926164
Report Number8030965-2020-03420
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819642379
UDI-Public(01)07611819642379
Combination Product (y/n)N
PMA/PMN Number
K131548
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 04/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.037.011
Device Lot NumberL425511
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2020
Date Manufacturer Received06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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