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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ADVANCED APPL OUTER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
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OBERDORF SYNTHES PRODUKTIONS GMBH ADVANCED APPL OUTER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 03.812.520
Device Problem Compatibility Problem (2960)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that during a surgery the instruments were sticking together and could not be disassembled.There was a surgical delay, however the amount of time is unknown.The surgery was successfully completed.The patient was reported to be in a normal status after the surgery.Concomitant devices reported: applicator inner shaft (part number 03.812.003, lot unknown, quantity 1), applicator knob (part number 03.812.004, lot unknown, quantity 1).This report involves one (1) t-pal spacer applicator handle.This is report 1 of 3 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.B3: event year is reported as 2020; however exact date of event is unknown.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.Investigation site: cq zuchwil selected flow: device interaction / functional.Visual inspection: the investigation has shown that the applicator knob is completely jammed at the advanced applicator outer shaft and can not released.The article is all in all in a good condition.Functional test: a functional test can not be performed of the jammed applicator knob at the advanced applicator outer shaft.Further attempts (with bench vice) failed to release the jammed connection.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the received condition agree with the complaint description and the complaint therefore is confirmed.The investigation has shown that the applicator knob is completely jammed at the advanced applicator outer shaft and can not released.The applicator knob has some dents visible which could made of a pliers.These indication led us assume that the device encountered unintended forces, such as a mechanical overload during an improper handling by release the connection (wrong direction), which finally caused the post manufacturing damages.By the evidence, that the device passed our 100% final inspection before the device left the manufacturing site we confirm that the cause of failure is not due to any manufacturing non-conformance.The connection thread conformed the specification at the time of manufacturing and passed inspection requirements.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are not required.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 lot part number: 03.812.520, lot number: 4l61255, manufacturing site: hägendorf, release to warehouse date: june 03, 2019.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.
 
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Brand Name
ADVANCED APPL OUTER SHAFT
Type of Device
INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10217419
MDR Text Key197124578
Report Number8030965-2020-04590
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07611819405813
UDI-Public(01)07611819405813
Combination Product (y/n)N
PMA/PMN Number
K151276
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 06/19/2020
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 Number03.812.520
Device Lot Number4L61255
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2020
Initial Date Manufacturer Received 06/19/2020
Initial Date FDA Received07/01/2020
Supplement Dates Manufacturer Received07/31/2020
08/13/2020
Supplement Dates FDA Received08/13/2020
08/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APPLICATOR INNER SHAFT; APPLICATOR KNOB; APPLICATOR INNER SHAFT; APPLICATOR KNOB
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