MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 286745500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Spinal Column Injury (2081)

Event Date 09/29/2017

Event Type  Injury  

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

In (b)(6) 2017, the patient has had a minimally invasive surgery with expedium viper.The construct included 18 screws inserted from t11 to pelvis, 2 open iliac connectors of 40mm, 1 cocro rod of 480mm cut by half for each of the sides and 20 innies.A revision surgery has been performed today because the rod on the left hand side of the patient had slided.One screw had no rod in its head anymore.The lordosis was not identical anymore on the two sides either.The patient also seemingly reported discomfort.During the revision surgery, all set screws have been removed.The surgeons have reported that on the left hand side, the set screws were loose from l3 to pelvis and on the right hand side, they were loose from l2 to pelvis.A very tiny portion of one set screw thread was found broken while removing the set screws.In addition, surgeons couldn't replace the innie of the iliac connector on the left hand side, as it was not holding properly anymore.They found out that the head of the connector had widened and due to the deformation, the set screw was not sitting in properly anymore.They have therefore decided to replace both iliac connectors too.Finally, they've replaced the 480mm cocro rod by a 480mm titanium rod.

Manufacturer Narrative

(b)(4).One viper2 final tightener handle (product code: 2867-45-500, lot number: gb79561) was returned to the customer quality unit for evaluation.The final tightener handle featured a light amount of superficial wear on its surface.The handle was submitted for torque testing.The handle failed a single torque test of the 18 performed.It is unknown why the torque handle could be torqueing slightly below intended values.The handle was not submitted for disassembly.Separating the components from one another would disrupt its functionality, potentially disrupting the cause of the reduced torque.Visual inspection would not be immediately capable of determining a root cause from a collection of disassembled components.The device is comparatively new and has had a limited timeframe with which to accrue wear and tear to its components.The lack of torque may have contributed the set screws backing out postoperatively, since the torque wrenches were not exerting sufficient torque to tighten the set screws into place.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.No emerging trends were found requiring further actions.The root cause of the torque handle exerting less torque than intended cannot be determined from the sample and the information provided.A potential root cause cannot be determined using the available information, though wear to the internal components of the device may be a contributing factor.

• Brand Name: VIPER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7078993
• MDR Text Key: 93594164
• Report Number: 1526439-2017-11023
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10705034214863
• UDI-Public: (01)10705034214863
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 286745500
• Device Catalogue Number: 286745500
• Device Lot Number: GB79561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR