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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH APPLICAT OUT SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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SYNTHES GMBH APPLICAT OUT SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 03.812.001
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2023
Event Type  malfunction  
Event Description
Device report from synthes reports an event in norway as follows: it was reported that the inserter has a bent hook, which bends out laterally in the distal part.This is dangerous in relation to introducing the instrument into the pt.It is somewhat uncertain when and how this happened during surgery.When it was discovered, they switched to the other inserter on the set.The surgery time was extended for 15-20 minutes.The surgery was successfully completed.No injury to the patient at the moment.This report is for one (1) applicat out shaft.This is report 1 of 1 for complaint (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.Additional narrative: the device has been 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product#: 03.812.001; lot #: 8181012; release to warehouse date: 11 jan 2013; manufacturing site: werk hagendorf; suppliers: na; expiration date: na.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of applicat out shaft, p/n: 03.812.001, was bent.No other problems identified.A dimensional inspection was unable to be performed due to not being applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the applicat out shaft, p/n: 03.812.001 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
APPLICAT OUT SHAFT
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key16224935
MDR Text Key309062771
Report Number8030965-2023-00759
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07611819405813
UDI-Public(01)07611819405813
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K151276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.812.001
Device Lot Number8181012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/02/2023
Initial Date FDA Received01/23/2023
Supplement Dates Manufacturer Received01/26/2023
Supplement Dates FDA Received02/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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