MAUDE Adverse Event Report: DEPUY SPINE INC CONN O/O SD TOP NTCH 5.5X5.5 T; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179771555

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4), unknown.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

It was reported that the posterior spine fusion surgery was performed on (b)(6) 2019 due to thoracic lumbar spinal canal stenosis after olif to fix th9/sai with expedium system.In order to do the reinforcement of fixation, the surgeon choose double rod technique with re bend rod and universal connector (p/n: 179771555) from lumbar to sai.However, the surgeon felt strange feeling when the surgeon performed final tightening of the set screw, so that the surgeon removed the set screw.Then, it was reported that the surgeon recognized that the there was a cross thread at the set screw.Thus, the surgeon replaced the set screw and universal connector, and was able to complete the surgery.There was no broken fragment in the patient¿s body.There was less than 30 min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Visual examination found that the initial thread on the connector were torn.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head of the connector.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.With the information provided, a definitive root cause for the torn threads on the conn o/o sd top ntch 5.5x5.5 t cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head of the connector.It should be noted that tightening the setscrew when it is cross threaded places force on the setscrew and the tulip head¿s threads that can result in them being torn.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, 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: CONN O/O SD TOP NTCH 5.5X5.5 T
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8689825
• MDR Text Key: 147730546
• Report Number: 1526439-2019-51749
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179771555
• Device Catalogue Number: 179771555
• Device Lot Number: NW226086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2018
• 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