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

Model Number 279734000N

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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

The patient had a t10-s1 posterior spinal fusion with depuy expedium 5.5mm ti rod system on (b)(6) 2018.The left rod ran from t10-l5 and the right side ran from t10-s1 - on both sides there were a number of levels that no screws were placed.According to dr.(b)(6) the patient had a solid fusion in the lumbar spine.At an unknown time, the right s1 screw came loose from the rod.It is unknown how this was determined.There were no issue with the left side hardware.Dr.(b)(6) commented that he probably should have initially taken the construct to the ilium.He said that the patient was large and that there was too much stress on the hardware.On (b)(6) 2018 dr.(b)(6) performed the revision.Dr.(b)(6) cut the existing rods around the l4 level.He removed the distal parts of these rods.He then placed new screws in the left s1 pedicle and the right l5 pedicle (there were no screws here from the previous case.He then placed iliac screws in the patient.While putting in the right iliac screw (9.0 x 90mm) the tip of the expedium nav driver ((b)(4)) broke off in the head of the screw.I need a replacement for this driver.I will send in the broken one.Dr.(b)(6) used a metal cutting burr to cut and remove the driver tip from the screw.He said that he got all of the driver tip out.It was sucked up into the suction cannister.Dr.(b)(6) then used expedium 5.5mm to 5.5mm rod to rod connectors and connected them to the existing rods.He then contoured new rods and connected them to the rod to rod connectors.He then connected the new rods to the screws at l5-ilium.He then final tightened everything and successfully completed the procedure.Height and weight are unknown the part #'s for the screws at left l5 and right s1 from the previous surgery are unknown - these were not removed this is all the information that is available.The distal rods that were cut and the expedium locking cap that was removed was discarded.I need a replacement for the (b)(4) x 1.The broken one will be sent back.Patient consequence? :no is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination of the returned device revealed the fracture is located at the driver¿s distal tip.The second half of the driver tip was not returned for analysis.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.No material defects or other abnormalities have been identified in the fracture analysis report.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.

• Brand Name: 5.5 VIPER UNIV POLY DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7352404
• MDR Text Key: 103276504
• Report Number: 1526439-2018-50251
• 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: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

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
• Device Lot Number: GM4618101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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: 62 YR