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U.S. Department of Health and Human Services

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

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SYNTHES GMBH APPLICATOR INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 03.812.003
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2023
Event Type  malfunction  
Event Description
Device report from synthes reports an event in united kingdom as follows: it was reported that on (b)(6) 2023, during the assembly of t-pal inserter construct, applicator inner shaft was not seating correctly in the outer sleeve.It was removed and noticed ball on the proximal end of the shaft has snapped off.There was no evidence of this piece of metal in the tray or in theatre, and could have occurred during cleaning or during disassembly in a previous surgery but noticed today.There were no issues notices today as used the other inner shaft on the tray and will continue to use the other inserter until damaged inserter shaft can be replaced.This report is for one (1) applicator inner 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.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.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.
 
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Brand Name
APPLICATOR INNER 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 Key16479640
MDR Text Key310866280
Report Number8030965-2023-02624
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07611819414600
UDI-Public(01)07611819414600
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K151276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
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 Number03.812.003
Device Lot Number7941936
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/11/2023
Initial Date FDA Received03/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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