MAUDE Adverse Event Report: DEPUY SYNTHES SPINE INNER SET SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 188342200

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Attempted to place h/h link on c5.Placed inner nut.Did not torque.Placed xlink then outer nut.Hand tightened inner nut.White knuckle, then torque outer nut, then attempted to torque inner but it would not get tight/torque.Removed xlink construct.Threads of inner nut was in poly screw.Repeated with new implants and same sequence same failure.Left construct without xlink.

Manufacturer Narrative

(b)(4).Three (3) mntr h/h x-conn inner screw were returned for evaluation.The inner screw featured most of its thread torn off from the start of the body with drive feature damaged as well while the outer nut was also found to have its thread damaged at its start.This damage may have occurred due to cross threading the outer nut on the inner screws upon insertion.Tightening an outer nut while it is cross threaded places an unexpectedly high amount of force on the threads of bot the nut and the inner screw, resulting in them being damaged or torn.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.A definitive root cause of the outer and inner screws¿ threads being torn cannot be determined from the samples and the information provided.A potential root cause may be due to inadvertently cross-threading of the screws during insertion and subsequent attempts to tighten the screws, placing enough force on the threads could have tear them off on one side before building up stresses again on the next rotation.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 requiring immediate action have been observed, 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: INNER SET SCREW
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6518674
• MDR Text Key: 73600136
• Report Number: 1526439-2017-10292
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151885
• 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,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 188342200
• Device Lot Number: BDIX2SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1