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

Model Number 279734000N

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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 that dr.(b)(6) was performing a lumbar spine revision on (b)(6) 2018.The patient had a non union at l5-s1 from a previous surgery from l3-s1 with competitive non depuy synthes spine hardware.During the revision, he removed all the competitive posterior hardware that was placed from l3-s1.He then place depuy expedium hardware in the existing screw holes from l3-s1 and he also extended the construct to the ilium.While placing the left l5 expedium screw (8.0 x 50mm) he had an issue of the expedium universal nav driver breaking (279734000n) while inserting the screw.The tip of the driver broke off in the screw.While driving this screw there was a lot of insertional torque.He did not tap the screw tract before inserting the screw.The screw was not fully inserted so he was able to use vise grips to use the screw shaft to remove the screw.He then inserted a new 8.0 x 50mm expedium screw with a standard expedium driver (279712400).He had a similar problem in the final turn of the screw.He could not advance the screw or remove it with the driver.Finally he tried to advance it a bit and this driver tip broke off.He elected to leave this screw in place as there was not way to remove it.The tip of the driver from the 279712400 remains in the patient.He then successfully completed the procedure.Time delay was about 15 minutes with no additional fluoroscopy due the issues.Patient consequence? :no.

• Brand Name: 5.5 VIPER UNIV POLY DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8171071
• MDR Text Key: 131774229
• Report Number: 1526439-2018-51148
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: (01)10705034388410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2018

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 Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/17/2018
• 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
• Patient Sequence Number: 1
• Patient Age: 45 YR