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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 VIPER UNIV POLY DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDOS INTERNATIONAL SàRL CH 5.5 VIPER UNIV POLY DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 279734000N
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported, during insertion of implant, the navigation driver tip broke off in implant. Implant was removed and replaced. Patient had sclerotic bone. One minute delay reported.
 
Manufacturer Narrative
Product complaint # (b)(4). Visual examination at the macroscopic level revealed that the fracture was located at the driver¿s distal tip. The second half of the driver was not returned for evaluation. Device was then sent for fracture analysis. The fracture analysis report reveals plastic deformation at the hexlobes and torsional shear markings following a circular pattern. This suggests that the fractured tip underwent a quasi-static overload torsional shear failure. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting. A definitive root cause for the poly driver¿s distal tip fracturing cannot be positively determined. However, the fracture analysis report suggests that the fractured tip underwent a quasi-static overload torsional shear failure. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required. 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 Name5.5 VIPER UNIV POLY DRIVER
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7391641
MDR Text Key104272431
Report Number1526439-2018-50290
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number279734000N
Device Catalogue Number279734000N
Device Lot NumberGM4735201
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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