MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONNECTOR SINGLE INLINE WITH INTEGRATED ROD 5.5X5.5 TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179776555

Device Problems Misassembled (1398); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

Udi: (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.Sample not returned.

Event Description

Revision t/l fusion.It has been noted that the two in-line rod connectors (179776555) which were removed from the patient for revision purposes contained two different sized grub screws.These devices were insitu from a previous operation and may have contributed to the revision.Two new in-line rod connectors (179776555) were sent within the expedium universal connector tray, however neither of these contained a grub screw.A slight delay in procedure to obtain grub screws that worked which were pulled out of items (1x 177092060 and 1x177092020 ) for the device to be implanted.Nil adverse event, however this issue may have contributed to the revision query.The surgeon would like to receive a report regarding this matter.Items removed for decontamination and retrieval/ grub screws located to fit devices missing.Five minutes delay in case.Xray images available.

Manufacturer Narrative

(b)(4).Two (2) expedium inline rod 5.5x5.5 ti were returned for evaluation.The rods contained two grub screws.Visual examination of the inline rods show signs of operative usage.Functional analysis was performed with x25 inserter (product code: 2797-12-590).It was noted that the one of the grub screws was functioning as intended, while there was some resistance in the usage of the second grub screw with its threads slightly worn.Both that grub screws have surface indications of rod striations, indicating full rod contact upon final tightening.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.With the information provided, a definitive root cause for the migration / backing out of the rod connector cannot be determined.However, a possible root cause can be due to using of different sized grub screws to tighten the rods, as reported in the compliant.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: CONNECTOR SINGLE INLINE WITH INTEGRATED ROD 5.5X5.5 TI
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 6360687
• MDR Text Key: 68405273
• Report Number: 1526439-2017-10140
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• 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: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 179776555
• Device Lot Number: TBLYK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR