MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER T27 ILIAC SCREW 9X90, TI; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 179706990

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the viper screw reveals signs of operative use as evidenced by superficial markings, with its threads completely peeled off and damage to the drive feature of the screw head.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.With the information provided, a definitive root cause for the torn threads on the viper screw cannot be determined.This damage may have potentially occurred due to cross-threading a set screw upon insertion.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.

Event Description

It was reported that while the surgeon was torqueing the set screw at the end of the case at normal 80 then wanted to torque at 100.When doing so, the set screw stripped out and compromised the inner screw threads of the screw.Pulled the screw out and replaced it.No adverse event and prolonged surgery.

• Brand Name: VIPER T27 ILIAC SCREW 9X90, TI
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS SARL INT'L; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7695385
• MDR Text Key: 114678032
• Report Number: 1526439-2018-50696
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034266589
• UDI-Public: (01)10705034266589
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179706990
• Device Catalogue Number: 179706990
• Device Lot Number: TBTKX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1